Panels › Anesthesiology › Product code BZK · Class 2
Spirometer, Monitoring (W/Wo Alarm)
Regulation 868.1850
1510(k)s in 12 months (62 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in BZK
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics Novametrix, Inc. | 4 | 2 |
| Respitrace Corp. | 6 | 0 |
| Respiratory Motion | 5 | 0 |
| Bear Medical Systems, Inc. | 4 | 0 |
| Ohmeda Medical | 4 | 0 |
| Boehringer Laboratories | 3 | 0 |
| Ohio Medical Products | 3 | 0 |
| Cairco , Ltd. | 2 | 0 |
| Cybermedic, Inc. | 2 | 0 |
| Empire Plastics Manufacturer | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 1982 | K822912 | BEAR VM-90 VENTILATION MONITOR Bear Medical Systems, Inc. | BZK |
| Jan 22, 1982 | K812959 | SPIROX A Cairco , Ltd. | BZK |
| Jan 22, 1982 | K812956 | SPIROX H Cairco , Ltd. | BZK |
| Aug 7, 1981 | K812046 | TIDAL VOLUME MONITOR 150 Medix Medical Electronics (U.S.A.), Inc. | BZK |
| May 8, 1980 | K800086 | RMS 111F RESPIRATORY MONITORING SYSTEM The Perkin-Elmer Corp. | BZK |
| Dec 31, 1979 | K792573 | ALARM USED W/MONITORING SPIROMETER Empire Plastics Manufacturer | BZK |
| Dec 19, 1979 | K792572 | EMPIRE SPIROMETER Empire Plastics Manufacturer | BZK |
| Jan 31, 1979 | K782145 | SPIROMETER, MINI POSITIVE Boehringer Laboratories | BZK |
| Jan 31, 1978 | K780064 | SPIROMETER, MONITORING W/ALARM Ohio Medical Products | BZK |
| Jan 26, 1978 | K772016 | RESPITRACE Respitrace Corp. | BZK |
| Jul 5, 1977 | K770907 | SPIROMETEO EXHAUST Timeter Instrument Corp. | BZK |
| Dec 9, 1976 | K760971 | POSITIVE DISPLACEMENT SPIROMETER Boehringer Laboratories | BZK |
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