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FDA 510(k)

MANUAL DISPOSABLE PULMONARY RESUSCITATOR

K-Number: K895169 · 1989-10-13

ApplicantF.L.W. Plastics, Inc.
Decision Date1989-10-13
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MANUAL DISPOSABLE PULMONARY RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is F.L.W. Plastics, Inc.. It received FDA 510(k) clearance on 1989-10-13 under 510(k) number K895169. 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 MANUAL DISPOSABLE PULMONARY RESUSCITATOR?

MANUAL DISPOSABLE PULMONARY RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is F.L.W. Plastics, Inc.. The 510(k) number is K895169.

When did MANUAL DISPOSABLE PULMONARY RESUSCITATOR receive FDA 510(k) clearance?

MANUAL DISPOSABLE PULMONARY RESUSCITATOR received FDA 510(k) clearance on 1989-10-13, under 510(k) number K895169.

Who is the listed applicant for MANUAL DISPOSABLE PULMONARY RESUSCITATOR?

The FDA 510(k) record lists F.L.W. Plastics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL DISPOSABLE PULMONARY RESUSCITATOR?

The FDA product code for MANUAL DISPOSABLE PULMONARY 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 F.L.W. Plastics, 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.

K900291MASS SPECTROMETRY MONITORING LINES AND CONNECTORSK895233BACTERIAL AND VIRAL FILTERK895357ANETHESIA BREATHING CIRCUIT

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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