S & W Medico Teknik
Walker, MI, US
S & W Medico Teknik appears in FDA device records in Walker, MI. FDA records list 49 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 49
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 49 510(k) clearances for S & W Medico Teknik between 1984 and 1997. The busiest year on record is 1989, with 14. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 14 |
| 1990 | 10 |
| 1991 | 6 |
| 1992 | 6 |
| 1993 | 4 |
| 1994 | 2 |
| 1995 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964593 | DIASCOPE TRAVELLER PLUS (4053) | DSI | Substantially Equivalent | |
| K940933 | 9267 SPO2 ATHENA MODULE | DQA | Substantially Equivalent | |
| K942196 | 3050 DIASCOPE NT PATIENT MONITOR | DSI | Substantially Equivalent | |
| K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA | LKD | Substantially Equivalent | |
| K934887 | 9750 ATHENA ETHERNET OPTION | DXK | Substantially Equivalent | |
| K915633 | MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA | FLL | Substantially Equivalent | |
| K930134 | 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT | DPS | Substantially Equivalent | |
| K923418 | 9293/1 INTERFACE MODULE | DQA | Substantially Equivalent | |
| K911611 | SYSTEM ATHENA, MODIFICATION | DRT | Substantially Equivalent | |
| K922314 | VENTILATOR INTERFACE 9291/4 | CBK | Substantially Equivalent | |
| K912815 | NIBP 9225 COMBI | DXN | Substantially Equivalent | |
| K912000 | TYPE INTERFACE 9271/1 INCUBATOR/WARMER | FMZ | Substantially Equivalent | |
| K912183 | TYPE 9050/NEO | DPS | Substantially Equivalent | |
| K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | CCE | Substantially Equivalent | |
| K912816 | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE | DSK | Substantially Equivalent | |
| K912049 | SYSTEM ATHENA - PRODUCT ENHANCEMENTS | DRT | Substantially Equivalent | |
| K903940 | TYPE 9210 S/ECG | DSI | Substantially Equivalent | |
| K911761 | SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION | DQA | Substantially Equivalent | |
| K905506 | ACCUCORE TELEMETRY, MODIFICATION | DSI | Substantially Equivalent | |
| K911264 | CALIBRATION KIT | BXK | Substantially Equivalent | |
| K900366 | ARRHYTHMIA 9215 | DSI | Substantially Equivalent | |
| K902779 | MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA | DQA | Substantially Equivalent | |
| K896738 | TYPE 9293 INTERFACE PULSEOX | DQA | Substantially Equivalent | |
| K884120 | TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) | BZQ | Substantially Equivalent | |
| K896700 | TYPE 9140/NEO | DRT | Substantially Equivalent | |
| K896699 | TYPE 9040/NEO | DRT | Substantially Equivalent | |
| K896737 | TYPE 9292 INTERFACE CAPNOGRAPH | CCK | Substantially Equivalent | |
| K896736 | TYPE 9291 INTERFACE RESPIRATOR | CBK | Substantially Equivalent | |
| K896735 | TYPE 9290 INTERFACE RESPIRATOR | CBK | Substantially Equivalent | |
| K895001 | TYPE EXPIRED CO2 9270, CAPNOGRAPH | CCK | Substantially Equivalent | |
| K895111 | TYPE 9541 RECORDER, PAPER CHART | DSF | Substantially Equivalent | |
| K894920 | SELECTRODE | DRX | Substantially Equivalent | |
| K894700 | TYPE PDU/CDU 9040 (SYSTEM ATHENA) | DRT | Substantially Equivalent | |
| K894699 | TYPE 9140 (SYSTEM ATHENA) | DRT | Substantially Equivalent | |
| K890005 | TYPE 9225 NIBP | DXN | Substantially Equivalent | |
| K884980 | F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM | DRX | Substantially Equivalent | |
| K884117 | TYPE 9210 ECG SYSTEM ATHENA | DRT | Substantially Equivalent | |
| K884116 | TYPE 9040 SYSTEM ATHENA | DPS | Substantially Equivalent | |
| K884122 | TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA | DXG | Substantially Equivalent | |
| K884121 | TYPE 9266 SAO2 SYSTEM ATHENA | DQA | Substantially Equivalent | |
| K884118 | TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA | DSK | Substantially Equivalent | |
| K884982 | M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68 | DRX | Substantially Equivalent | |
| K884981 | F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM | DRX | Substantially Equivalent | |
| K884984 | M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 | DRX | Substantially Equivalent | |
| K884983 | M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 | DRX | Substantially Equivalent | |
| K884119 | TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA | FLL | Substantially Equivalent | |
| K864586 | S&W ELECTRODE TYPES 888, 844, 988 AND 944 | DRX | Substantially Equivalent | |
| K851931 | DEFI 2 | LDD | Substantially Equivalent | |
| K833689 | DIASCOPE 2 | DRT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- FLLContinuous Measurement Thermometer
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- DXKEchocardiograph
- DPSElectrocardiograph
- DRXElectrode, Electrocardiograph
- BXKGas, Calibration (Specified Concentration)
- FMZIncubator, Neonatal
- BZQMonitor, Breathing Frequency
- LKDMonitor, Carbon-Dioxide, Cutaneous
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DQAOximeter
- DSFRecorder, Paper Chart
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- CBKVentilator, Continuous, Facility Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain