COMPUMEDICS SOMTE SYSTEM


Device Classification Name

ventilatory effort recorder

510(k) Number K021176
Device Name COMPUMEDICS SOMTE SYSTEM
Original Applicant
COMPUMEDICS LIMITED
6740 riverview terrace
minneapolis,, 
MN 
55432

Original Contact constance g bundy
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 04/12/2002
Decision Date 01/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No