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FDA 510(k)

VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

K-Number: K954150 · 1995-12-20

ApplicantGreen Field Medical Sourcing, Inc.
Decision Date1995-12-20
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Green Field Medical Sourcing, Inc.. It received FDA 510(k) clearance on 1995-12-20 under 510(k) number K954150. 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 VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)?

VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Green Field Medical Sourcing, Inc.. The 510(k) number is K954150.

When did VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) receive FDA 510(k) clearance?

VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) received FDA 510(k) clearance on 1995-12-20, under 510(k) number K954150.

Who is the listed applicant for VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)?

The FDA 510(k) record lists Green Field Medical Sourcing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)?

The FDA product code for VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) is BTM.

Related Clinical Trials

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Other records listing Green Field Medical Sourcing, Inc. 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.

K971759MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTERK971348FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEMK944667LIFE PULSE TESUSCITATION TIMERK932867LIFE PULSE RESUSCITATION TIMER

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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