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FDA 510(k)

SINGLE USE MANUAL RESUSCITATORS

K-Number: K905002 · 1991-03-29

ApplicantCustom Medical, Inc.
Decision Date1991-03-29
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SINGLE USE MANUAL RESUSCITATORS is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical, Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K905002. 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 SINGLE USE MANUAL RESUSCITATORS?

SINGLE USE MANUAL RESUSCITATORS is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Custom Medical, Inc.. The 510(k) number is K905002.

When did SINGLE USE MANUAL RESUSCITATORS receive FDA 510(k) clearance?

SINGLE USE MANUAL RESUSCITATORS received FDA 510(k) clearance on 1991-03-29, under 510(k) number K905002.

Who is the listed applicant for SINGLE USE MANUAL RESUSCITATORS?

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

What is the FDA product code for SINGLE USE MANUAL RESUSCITATORS?

The FDA product code for SINGLE USE MANUAL RESUSCITATORS 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 Custom Medical, 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.

K832758RED COLOR-TINTED TUBINGK830182CUSTOM IV SET

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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