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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K112822
Device Name SLEEPSTRIP II
Applicant
S.L.P. , Ltd.
62 Anilevitz St.
Tel-Aviv,  IL 67060
Applicant Contact NOAM HADAS
Correspondent
S.L.P. , Ltd.
62 Anilevitz St.
Tel-Aviv,  IL 67060
Correspondent Contact NOAM HADAS
Regulation Number868.2375
Classification Product Code
MNR  
Date Received09/28/2011
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
Predetermined Change
Control Plan Authorized		 No
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