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FDA 510(k)

DISPOSABLE BAG MASK ADEJUNCT

K-Number: K803066 · 1981-02-12

ApplicantT. S. Enterprises, Inc.
Decision Date1981-02-12
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE BAG MASK ADEJUNCT is the device name listed in this FDA 510(k) record. The listed applicant is T. S. Enterprises, Inc.. It received FDA 510(k) clearance on 1981-02-12 under 510(k) number K803066. 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 DISPOSABLE BAG MASK ADEJUNCT?

DISPOSABLE BAG MASK ADEJUNCT is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is T. S. Enterprises, Inc.. The 510(k) number is K803066.

When did DISPOSABLE BAG MASK ADEJUNCT receive FDA 510(k) clearance?

DISPOSABLE BAG MASK ADEJUNCT received FDA 510(k) clearance on 1981-02-12, under 510(k) number K803066.

Who is the listed applicant for DISPOSABLE BAG MASK ADEJUNCT?

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

What is the FDA product code for DISPOSABLE BAG MASK ADEJUNCT?

The FDA product code for DISPOSABLE BAG MASK ADEJUNCT 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 T. S. Enterprises, 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.

K823276BED GUARD

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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