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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 K021390
Device Name PMX COMPACT RESUCITATOR
Applicant
CHEEN HOUNG ENT. CO. LTD.
23 SAN DREEN ST., ALLEY 11,
LANE 65
TAIPEI (SHULIN),  TW 23805
Applicant Contact JAY WANG
Correspondent
CHEEN HOUNG ENT. CO. LTD.
23 SAN DREEN ST., ALLEY 11,
LANE 65
TAIPEI (SHULIN),  TW 23805
Correspondent Contact JAY WANG
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/02/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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