Instromedix, Inc.
San Diego, CA, US
Instromedix, Inc. appears in FDA device records in San Diego, CA. FDA records list 33 510(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
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Instromedix, Inc. between 1977 and 2001. The busiest year on record is 1995, with 4. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 2 |
| 1981 | 1 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 2 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K010945 | HEARTCARD, MODEL 5258 | DXH | Substantially Equivalent | |
| K964408 | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) | DPS | Substantially Equivalent | |
| K964036 | CARDIOMAGIC 2000 SOFTWARE | DXH | Substantially Equivalent | |
| K955060 | ACCELERATED TRANSMISSION PROTOCOL | DXH | Substantially Equivalent | |
| K951096 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER | DXH | Substantially Equivalent | |
| K945476 | HEARTHWATCH III(TM) | DXH | Substantially Equivalent | |
| K950003 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS | DXH | Substantially Equivalent | |
| K944362 | HEARTCARD CARDIAC EVENT MONITOR | DXH | Substantially Equivalent | |
| K943931 | CARRYALL ENHANCEMENTS | DXH | Substantially Equivalent | |
| K935586 | PRINCE | DXH | Substantially Equivalent | |
| K925639 | CARDIOMAGIC SOFTWARE | DXH | Substantially Equivalent | |
| K923221 | KING OF HEARTS SCEPTER | DPS | Substantially Equivalent | |
| K925809 | COMPRESSAR UNIVERSAL (TM) SYSTEM | DXC | Substantially Equivalent | |
| K920984 | KING OF HEARTS EXPRESS (E.X.) MONITOR | DXH | Substantially Equivalent | |
| K896040 | KING OF HEARTS CDM | DXH | Substantially Equivalent | |
| K896039 | KING OF HEARTS 1200 MONITOR | DXH | Substantially Equivalent | |
| K896002 | CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER | DXH | Substantially Equivalent | |
| K891000 | MODIFIED EXTERNAL PAD | DWS | Substantially Equivalent | |
| K881297 | BARO-GRAF 24 | DRS | Substantially Equivalent | |
| K880626 | KING OF HEARTS | DXH | Substantially Equivalent | |
| K844310 | BLOOD-PRESSURE ECG TRANSMITTER | DXN | Substantially Equivalent | |
| K842051 | EKG TRANSMITTER MODEL 5134 | DXY | Substantially Equivalent | |
| K840587 | INSTANT REPLAY | DXH | Substantially Equivalent | |
| K833809 | NEURAL STIMULATOR MONITOR | GZB | Substantially Equivalent | |
| K831337 | COMPRESSAR DISPOSABLE DISC | DQO | Substantially Equivalent | |
| K830477 | CARDIOMEMO III | DXH | Substantially Equivalent | |
| K803286 | CARDIOMEMO | KRE | Substantially Equivalent | |
| K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER | KRE | Substantially Equivalent | |
| K800405 | A-V MINI CLINIC | DRT | Substantially Equivalent | |
| K791892 | TAPE-A-TRACE | DXM | Substantially Equivalent | |
| K791762 | SELF CHECK | DTC | Substantially Equivalent | |
| K781349 | PACER-TRACER PULSE WIDTH | DTC | Substantially Equivalent | |
| K771922 | MINICLINIC TM | DTC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTCAnalyzer, Pacemaker Generator Function
- KREAnalyzer, Pacemaker Generator Function, Indirect
- DQOCatheter, Intravascular, Diagnostic
- DXCClamp, Vascular
- DXMDensitometer
- DPSElectrocardiograph
- DXYImplantable Pacemaker Pulse-Generator
- DWSInstruments, Surgical, Cardiovascular
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRSTransducer, Blood-Pressure, Extravascular
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
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