The following data is part of a premarket notification filed by Somnomedics Gmbh & Co. Kg with the FDA for Somnoscreen.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04250413404087 | K060708 | 000 |
04250413402014 | K060708 | 000 |
04250413400492 | K060708 | 000 |
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 |