MICHELE SLEEP SCORING SYSTEMS


Device Classification Name

ventilatory effort recorder

510(k) Number K112102
Device Name MICHELE SLEEP SCORING SYSTEMS
Applicant
YOUNES SLEEP TECHNOLOGIES
435 ellice avenue
winnipeg, manitoba, 

CA

r3b 1y6

Applicant Contact magdy younes
Correspondent
YOUNES SLEEP TECHNOLOGIES
435 ellice avenue
winnipeg, manitoba, 

CA

r3b 1y6

Correspodent Contact magdy younes
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 07/22/2011
Decision Date 12/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No