SOMNOWATCH
Ventilatory Effort Recorder
SOMNOMEDICS GMBH
The following data is part of a premarket notification filed by Somnomedics Gmbh with the FDA for Somnowatch.
Pre-market Notification Details
| Device ID | K081485 |
| 510k Number | K081485 |
| Device Name: | SOMNOWATCH |
| Classification | Ventilatory Effort Recorder |
| Applicant | SOMNOMEDICS GMBH 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James SOMNOMEDICS GMBH 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-28 |
| Decision Date | 2008-09-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250413405022 | K081485 | 000 |
| 04250413402755 | K081485 | 000 |
| 00833166000405 | K081485 | 000 |
| 00833166000412 | K081485 | 000 |
| 04250413401475 | K081485 | 000 |
| 04250413401666 | K081485 | 000 |
| 04250413401833 | K081485 | 000 |
| 04250413401857 | K081485 | 000 |
| 04250413400195 | K081485 | 000 |
| 04250413400218 | K081485 | 000 |
| 04250413400379 | K081485 | 000 |
| 04250413400409 | K081485 | 000 |
| 04250413400430 | K081485 | 000 |
| 04250413400560 | K081485 | 000 |
| 04250413404544 | K081485 | 000 |
| 04250413402748 | K081485 | 000 |
Trademark Results [SOMNOWATCH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMNOWATCH 78855772 3610439 Live/Registered |
Somnomedics GmbH & Co. 2006-04-06 |
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