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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 K221361
Device Name circul™ pro Ring
Applicant
BodiMetrics, LLC
1601 N. Sepulveda Blvd, Suite 839
Manhattan Beach,  CA  90266
Applicant Contact Mark Goettling
Correspondent
Nilo Medical Consulting Group, LLC
3491 Denny Street
Pittsburgh,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/11/2022
Decision Date 08/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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