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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 K252628
Device Name CASSIE
Applicant
Wesper, Inc.
44-02 11th St.
Suite 610
Long Island City,  NY  11101
Applicant Contact Ciaran Lynch
Correspondent
Wesper, Inc.
44-02 11th St.
Suite 610
Long Island City,  NY  11101
Correspondent Contact Ciaran Lynch
Regulation Number868.2375
Classification Product Code
MNR  
Date Received08/20/2025
Decision Date 04/27/2026
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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