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FDA 510(k)

ARTEC RESPOND PULMONARY RESUSCITATOR

K-Number: K896886 · 1990-02-06

ApplicantArtec Environmental Monitoring Division
Decision Date1990-02-06
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARTEC RESPOND PULMONARY 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 1990-02-06 under 510(k) number K896886. 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 ARTEC RESPOND PULMONARY RESUSCITATOR?

ARTEC RESPOND PULMONARY RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1990-02-06. The listed applicant is Artec Environmental Monitoring Division. The 510(k) number is K896886.

When did ARTEC RESPOND PULMONARY RESUSCITATOR receive FDA 510(k) clearance?

ARTEC RESPOND PULMONARY RESUSCITATOR received FDA 510(k) clearance on 1990-02-06, under 510(k) number K896886.

Who is the listed applicant for ARTEC RESPOND PULMONARY 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 ARTEC RESPOND PULMONARY RESUSCITATOR?

The FDA product code for ARTEC RESPOND PULMONARY 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 ROCKERK873043MOUTH TO FACE 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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