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FDA 510(k)

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

K-Number: K003927 · 2001-06-26

ApplicantCheen Houng Ent. Co. , Ltd.
Decision Date2001-06-26
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 is the device name listed in this FDA 510(k) record. The listed applicant is Cheen Houng Ent. Co. , Ltd.. It received FDA 510(k) clearance on 2001-06-26 under 510(k) number K003927. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02?

Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 is a medical device that received FDA 510(k) clearance on 2001-06-26. The listed applicant is Cheen Houng Ent. Co. , Ltd.. The 510(k) number is K003927.

When did Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 receive FDA 510(k) clearance?

Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 received FDA 510(k) clearance on 2001-06-26, under 510(k) number K003927.

Who is the listed applicant for Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02?

The FDA 510(k) record lists Cheen Houng Ent. Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02?

The FDA product code for Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 is BTM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Cheen Houng Ent. Co. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121587BREATH SHAKEK021390PMX COMPACT RESUCITATORK010191Y2000 POCKET RESCUEK9814150-20 CM H20 PEEP VALVEK970688POCKET RESCUE

Related Devices (Code: BTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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