SOMNOWATCH


Device Classification Name

ventilatory effort recorder

510(k) Number K081485
Device Name SOMNOWATCH
Applicant
SOMNOMEDICS GMBH
901 king street
suite 200
alexandria, 
VA 
22314

Applicant Contact cherita james
Correspondent
SOMNOMEDICS GMBH
901 king street
suite 200
alexandria, 
VA 
22314

Correspodent Contact cherita james
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 05/28/2008
Decision Date 09/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No