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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K221816
Device Name Wesper Lab
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 Number868.2375
Classification Product Code
MNR  
Date Received06/22/2022
Decision Date 03/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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