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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K181352
Device Name Loop System
Spry Health, Inc.
235 Alma Street
Palo Alto,  CA  94301
Applicant Contact Elad Ferber
Coombs Medical Device Consulting, Inc
1193 Sherman St
Alameda,  CA  94501
Correspondent Contact Craig Coombs
Regulation Number870.2700
Classification Product Code
Date Received05/22/2018
Decision Date 03/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No