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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 K220351
Device Name Polso Watch
Applicant
Chronisense Medical, Ltd.
2 Hacarmel St.
P.O.B. 399
Yokneam Illit,  IL 2066724
Applicant Contact Bridget Ross
Correspondent
RQM+
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/07/2022
Decision Date 11/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT03735329
NCT03750344
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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