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FDA 510(k)

HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR

K-Number: K002846 · 2001-06-06

ApplicantHeadstar Medical Products Co., Ltd.
Decision Date2001-06-06
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Headstar Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K002846. 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 HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR?

HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Headstar Medical Products Co., Ltd.. The 510(k) number is K002846.

When did HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR receive FDA 510(k) clearance?

HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR received FDA 510(k) clearance on 2001-06-06, under 510(k) number K002846.

Who is the listed applicant for HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR?

The FDA 510(k) record lists Headstar Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR?

The FDA product code for HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR 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 Headstar Medical Products 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.

K121770HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER

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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