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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2017 | Mindray DS USA, Inc. dba Mindray North America Gas Module 3 monitoring spirometer, Part Number: 115-030108-00
Product Usage:
The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. M Terminated |
BZK | K062754 |
| Sep 30, 2011 | Respironics Novametrix, LLC. FloTrak Elite modules
FloTrak Elite P/N 1044971
FloTrak Elite P/N 1051005 Terminated |
BZK | K080652 K091459 +1 |
| Sep 30, 2011 | Respironics Novametrix, LLC. PHILIPS NM3 Monitor Model Number: 7900
PHILIPS NM3 Monitor, English
Part Number: 1051674
PHILIPS NM3 Monitor, English, Refurbished
Part Number : U1051674
PHILIPS NM3 Monitor, English, Demo Unit
Part N Terminated |
BZK | K080652 K091459 +1 |
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