COMPUMEDICS SOMTE PSG RECORDING SYSTEM


Device Classification Name

ventilatory effort recorder

510(k) Number K072201
Device Name COMPUMEDICS SOMTE PSG RECORDING SYSTEM
Applicant
COMPUMEDICS LIMITED
30-40 flockhart street
abbotsford
melbourne, victoria, 

AU

3067

Applicant Contact gordon ferguson
Correspondent
COMPUMEDICS LIMITED
30-40 flockhart street
abbotsford
melbourne, victoria, 

AU

3067

Correspodent Contact gordon ferguson
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 08/08/2007
Decision Date 04/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No