SOMNOSCREEN
Ventilatory Effort Recorder
SOMNOMEDICS GMBH & CO. KG
The following data is part of a premarket notification filed by Somnomedics Gmbh & Co. Kg with the FDA for Somnoscreen.
Pre-market Notification Details
| Device ID | K060708 |
| 510k Number | K060708 |
| Device Name: | SOMNOSCREEN |
| Classification | Ventilatory Effort Recorder |
| Applicant | SOMNOMEDICS GMBH & CO. KG 719 A STREET NE Washington, DC 20002 |
| Contact | Cherita James |
| Correspondent | Cherita James SOMNOMEDICS GMBH & CO. KG 719 A STREET NE Washington, DC 20002 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-16 |
| Decision Date | 2007-01-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250413404087 | K060708 | 000 |
| 04250413402014 | K060708 | 000 |
| 04250413400492 | K060708 | 000 |
Trademark Results [SOMNOSCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMNOSCREEN 85748831 4346500 Live/Registered |
SOMNOmedics GmbH 2012-10-09 |
 SOMNOSCREEN 78151829 not registered Dead/Abandoned |
Somnomedics GmbH & Co. 2002-08-07 |
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