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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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