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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K243861
Device Name butterflyBVM
Applicant
Compact Medical, Inc.
525 S. Meridian St.
Suite 2d2
Indianapolis,  IN  46259
Applicant Contact Jonathan Merrell
Correspondent
RQM+
2790 Mosside Blvd.
Suite 800
Monroeville,  PA  15146
Correspondent Contact Allison Komiyama
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/16/2024
Decision Date 04/25/2025
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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