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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 K203343
Device Name Wesper Lab
Applicant
Wesper Inc.
234 5th Avenue
New York,  NY  10001
Applicant Contact Amir Reuveny
Correspondent
Wesper Inc.
234 5th Avenue
New York,  NY  10001
Correspondent Contact Amir Reuveny
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
BZQ  
Date Received11/13/2020
Decision Date 12/21/2021
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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