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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 K984169
Device Name DIGI-SNAP
Applicant
SNAP LABORATORIES, L.L.C.
3633 WEST LAKE AVE., SUITE 406
GLENVIEW,  IL  60025
Applicant Contact GIL RAVIV
Correspondent
SNAP LABORATORIES, L.L.C.
3633 WEST LAKE AVE., SUITE 406
GLENVIEW,  IL  60025
Correspondent Contact GIL RAVIV
Regulation Number868.2375
Classification Product Code
MNR  
Date Received11/20/1998
Decision Date 05/26/1999
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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