The following data is part of a premarket notification filed by Somnomedics Gmbh with the FDA for Somnowatch.
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 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOMNOWATCH 78855772 3610439 Live/Registered |
Somnomedics GmbH & Co. 2006-04-06 |