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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 K110064
Device Name SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
Applicant
SNAP DIAGNOSTICS, L.L.C.
5210 Capitol Dr
WHEELING,  IL  60090
Applicant Contact GIL RAVIV
Correspondent
SNAP DIAGNOSTICS, L.L.C.
5210 Capitol Dr
WHEELING,  IL  60090
Correspondent Contact GIL RAVIV
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/10/2011
Decision Date 03/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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