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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 K241090
Device Name Evie Med Ring
Applicant
Movano Inc. Dba Movano Health
6800 Koll Center Pkwy., Suite 160
Pleasanton,  CA  94566
Applicant Contact Kim Tompkins
Correspondent
Movano Inc. Dba Movano Health
6800 Koll Center Pkwy., Suite 160
Pleasanton,  CA  94566
Correspondent Contact Kim Tompkins
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/22/2024
Decision Date 11/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT05920278
NCT06101654
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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