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FDA 510(k)

RESUSCITATION MASK

K-Number: K820059 · 1982-03-26

ApplicantCederroth, Inc. USA
Decision Date1982-03-26
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESUSCITATION MASK is the device name listed in this FDA 510(k) record. The listed applicant is Cederroth, Inc. USA. It received FDA 510(k) clearance on 1982-03-26 under 510(k) number K820059. 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 RESUSCITATION MASK?

RESUSCITATION MASK is a medical device that received FDA 510(k) clearance on 1982-03-26. The listed applicant is Cederroth, Inc. USA. The 510(k) number is K820059.

When did RESUSCITATION MASK receive FDA 510(k) clearance?

RESUSCITATION MASK received FDA 510(k) clearance on 1982-03-26, under 510(k) number K820059.

Who is the listed applicant for RESUSCITATION MASK?

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

What is the FDA product code for RESUSCITATION MASK?

The FDA product code for RESUSCITATION MASK is BTM.

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Other records listing Cederroth, Inc. USA 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.

K880788NON ADHERENT PADK823057MEDICATED ADHESIVE STRIPK830330SAVETT ALCOHOL PREPK813365MULTIPLE BANDAGE OR DRESSINGK813364MEDICAL TAPE (MULTIPLE)K813361ADHESIVE STRIP(MULTIPLE)

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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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