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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 K213515
Device Name WesperO2
Applicant
Wesper, Inc.
234 5th Ave.
New York,  NY  10001
Applicant Contact Amir Reuveny
Correspondent
Wesper, Inc.
234 5th Ave.
New York,  NY  10001
Correspondent Contact Amir Reuveny
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/02/2021
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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