Protocol Systems, Inc.
Beaverton, OR, US
Protocol Systems, Inc. appears in FDA device records in Beaverton, OR. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Protocol Systems, Inc. between 1988 and 2000. The busiest year on record is 1991, with 3. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002725 | MICROPAQ, MODELS 402 AND 404 | DRT | Substantially Equivalent | |
| K972121 | ACUITY CENTRAL STATION | MLD | Substantially Equivalent | |
| K951246 | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS | FLS | Substantially Equivalent - Subject to Tracking Reg. | |
| K945071 | PROPAQ 200 MONITOR | DRT | Substantially Equivalent | |
| K935846 | MODEL ACUITY CENTRAL STATION | DSI | Substantially Equivalent | |
| K934711 | PROPAQ ECG TELEMETRY OPTION | DRG | Substantially Equivalent | |
| K921497 | PROPAQ MONITORS, MODIFICATION | CCK | Substantially Equivalent | |
| K914838 | PROPAQ 102,104,106,102EL,104EL,&106EL | MHX | Substantially Equivalent | |
| K913193 | MODEL 100 CENTRAL STATION | DQK | Substantially Equivalent | |
| K910882 | PROPAQ 102EL, 104EL AND 106EL | DRT | Substantially Equivalent | |
| K910772 | PROPAQ 102, 104 AND 106 | DXN | Substantially Equivalent | |
| K902730 | SPO2 OPTION | DQA | Substantially Equivalent | |
| K894607 | PAQ10 PAPER CHART RECORDER | DSF | Substantially Equivalent | |
| K884320 | PROPAQ 106(TM) | DRT | Substantially Equivalent | |
| K882085 | PROPAQ 104(TM) | DSK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- DSIDetector And Alarm, Arrhythmia
- FLSMonitor, Apnea, Facility Use
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- DQAOximeter
- DSFRecorder, Paper Chart
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
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