Panels › Anesthesiology › Product code BZQ · Class 2
Monitor, Breathing Frequency
Regulation 868.2375
2510(k)s in 12 months (176 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in BZQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Aequitron Medical, Inc. | 9 | 0 |
| Earlysense, Ltd. | 8 | 0 |
| Healthdyne, Inc. | 8 | 0 |
| Edentec Corp. | 6 | 0 |
| Ge Medical Systems Information Technologies | 6 | 0 |
| Braebon Medical Corp. | 4 | 0 |
| Arvee Medical, Inc. | 3 | 0 |
| Epm Information Systems, Inc. | 3 | 0 |
| Gereonics, Inc. | 3 | 0 |
| Honeywell, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2011 | Salter Laboratories, Division of Regulatory Affairs ThermiSense model 5700-A5
The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via Terminated |
BZQ | K080922 |
| Jul 27, 2004 | Respironics, Inc. Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter. Terminated |
BZQ | None listed |
| Jul 20, 2004 | CAS Medical Systems, Inc. Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0 Terminated |
BZQ | K962781 |
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