SLEEPSTRIP II


Device Classification Name

ventilatory effort recorder

510(k) Number K112822
Device Name SLEEPSTRIP II
Applicant
S.L.P LTD.
62 anilevitz street
tel-aviv, 

IL

67060

Applicant Contact noam hadas
Correspondent
S.L.P LTD.
62 anilevitz street
tel-aviv, 

IL

67060

Correspodent Contact noam hadas
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 09/28/2011
Decision Date 12/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No