Y2000 Manual Resuscitator, Model RUGU01/RUG02 and RUGH01/RUGH02

FDA 510(k) K003927 · Cheen Houng Ent. Co. , Ltd.

Substantially Equivalent

510(k) numberK003927

Submission

Device name
Y2000 Manual Resuscitator, Model RUGU01/RUG02 and RUGH01/RUGH02
Applicant
Cheen Houng Ent. Co. , Ltd.
Taipei (Shulin), TW
Received
December 20, 2000
Decision date
June 26, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTM – Ventilator, Emergency, Manual (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5915
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BTM

510(k)DeviceApplicantDecision
K251631The BAG manual resuscitator and accessoriesBTM · Traditional Laerdal Medical AS11/24/2025SE
K243861butterflyBVMBTM · Traditional Compact Medical, Inc.04/25/2025SE
K221841EOlife®BTM · Traditional Archeon03/18/2023SE
K212905Sotair DeviceBTM · Traditional Safe Bvm Corporation08/18/2022SE
K210288Disposable Manual ResuscitatorBTM · Traditional Xiamen Compower Medical Tech. Co., Ltd.08/26/2021SE
K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional Flexicare Medical Limited.12/07/2018SE
K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional Foremount Enterprise Co., Ltd.05/11/2018SE
K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated Ambu A/S08/29/2016SE
K132172Neonatalie ResuscitatorBTM · Abbreviated Laerdal Medical A/S01/15/2015SE
K112852Babi Plus Neonatal Resuscitation BagBTM · Traditional A Plus Medical01/13/2012SE

More from A Plus Medical

510(k)DeviceDecision
K121587Breath ShakeBYI · Traditional 11/22/2013SE
K021390PMX Compact ResucitatorBTM · Traditional 10/04/2002SE
K010191Y2000 Pocket RescueCBP · Traditional 03/14/2001SE
K9814150-20 CM H20 Peep ValveBYE · Traditional 07/14/1998SE
K970688Pocket RescueKGB · Traditional 09/26/1997SE

Questions and answers

When was Y2000 Manual Resuscitator, Model RUGU01/RUG02 and RUGH01/RUGH02 cleared by the FDA?

Y2000 Manual Resuscitator, Model RUGU01/RUG02 and RUGH01/RUGH02 (K003927) received a 510(k) decision of Substantially Equivalent on June 26, 2001, 188 days after the submission was received.

What is the product code of K003927?

The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.