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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Non-Life-Supporting
510(k) Number K252078
Device Name BreathePal Bilevel (GFM50-MD2201)
Applicant
Compal Electronics, Inc.
# 581 And 581-1, Ruiguang Rd., Neihu Dist.
Taipei City,  TW 11492
Applicant Contact Casper Chen
Correspondent
Compal Electronics, Inc.
# 581 And 581-1, Ruiguang Rd., Neihu Dist.
Taipei City,  TW 11492
Correspondent Contact Casper Chen
Regulation Number868.5895
Classification Product Code
MNS  
Date Received07/02/2025
Decision Date 03/17/2026
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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