Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02

Ventilator, Emergency, Manual (resuscitator)

CHEEN HOUNG ENT. CO. LTD.

The following data is part of a premarket notification filed by Cheen Houng Ent. Co. Ltd. with the FDA for Y2000 Manual Resuscitator, Model Rugu01/rug02 And Rugh01/rugh02.

Pre-market Notification Details

Device IDK003927
510k NumberK003927
Device Name:Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant CHEEN HOUNG ENT. CO. LTD. 23 ALLEY 11 LANE 65 SAN DREEN STREET Taipei (shulin),  TW 23805
ContactJay Wang
CorrespondentJay Wang
CHEEN HOUNG ENT. CO. LTD. 23 ALLEY 11 LANE 65 SAN DREEN STREET Taipei (shulin),  TW 23805
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-20
Decision Date2001-06-26

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