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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 STREET
TEL-AVIV,  IL 67060
Applicant Contact NOAM HADAS
Correspondent
S.L.P LTD.
62 ANILEVITZ STREET
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
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