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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 Drive
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
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