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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 K240100
Device Name SAM Model 9-10000
Applicant
Snap Diagnostics, LLC
616 Atrium Dr.
Suite 100
Vernon Hills,  IL  60061
Applicant Contact Gil Raviv
Correspondent
Vision28
915 SW Rimrock Way Suite 201-402
Redmond,  OR  97756
Correspondent Contact Tom Renner
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/12/2024
Decision Date 06/04/2024
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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