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FDA 510(k)

MOUTH TO FACE RESUSCITATOR

K-Number: K873043 · 1987-09-28

ApplicantArtec Environmental Monitoring Division
Decision Date1987-09-28
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTH TO FACE RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Artec Environmental Monitoring Division. It received FDA 510(k) clearance on 1987-09-28 under 510(k) number K873043. 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 MOUTH TO FACE RESUSCITATOR?

MOUTH TO FACE RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1987-09-28. The listed applicant is Artec Environmental Monitoring Division. The 510(k) number is K873043.

When did MOUTH TO FACE RESUSCITATOR receive FDA 510(k) clearance?

MOUTH TO FACE RESUSCITATOR received FDA 510(k) clearance on 1987-09-28, under 510(k) number K873043.

Who is the listed applicant for MOUTH TO FACE RESUSCITATOR?

The FDA 510(k) record lists Artec Environmental Monitoring Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUTH TO FACE RESUSCITATOR?

The FDA product code for MOUTH TO FACE RESUSCITATOR is BTM.

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Other records listing Artec Environmental Monitoring Division 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.

K900839THE CAROLINA ROCKERK896886ARTEC RESPOND PULMONARY RESUSCITATORK863910RAINCOATK854573ANESTHESIA SHUTOFF VALVE POSITIVE CLOSUREK832512AIRWAY MASKSK830056ARTEC TWIST VALVE

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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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