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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 K971184
Device Name OXI-SNAP
Applicant
Snap Laboratories, LLC
3633 W. Lake Ave., Suite 406
Glenview,  IL  60025
Applicant Contact GIL RAVIV
Correspondent
Snap Laboratories, LLC
3633 W. Lake Ave., Suite 406
Glenview,  IL  60025
Correspondent Contact GIL RAVIV
Regulation Number868.2375
Classification Product Code
MNR  
Date Received04/01/1997
Decision Date 10/01/1997
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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