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FDA 510(k)

AMBU RESUSCITATOR

K-Number: K771350 · 1977-08-19

ApplicantAir-Shields, Inc.
Decision Date1977-08-19
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1977-08-19 under 510(k) number K771350. 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 AMBU RESUSCITATOR?

AMBU RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1977-08-19. The listed applicant is Air-Shields, Inc.. The 510(k) number is K771350.

When did AMBU RESUSCITATOR receive FDA 510(k) clearance?

AMBU RESUSCITATOR received FDA 510(k) clearance on 1977-08-19, under 510(k) number K771350.

Who is the listed applicant for AMBU RESUSCITATOR?

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

What is the FDA product code for AMBU RESUSCITATOR?

The FDA product code for AMBU RESUSCITATOR is BTM.

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Other records listing Air-Shields, Inc. as applicant

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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

View on FDA Database →

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

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