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FDA 510(k)

RESUSCI PATIENT FACE SHIELD

K-Number: K880450 · 1988-03-04

ApplicantLaerdal Medical Corp.
Decision Date1988-03-04
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESUSCI PATIENT FACE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical Corp.. It received FDA 510(k) clearance on 1988-03-04 under 510(k) number K880450. 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 RESUSCI PATIENT FACE SHIELD?

RESUSCI PATIENT FACE SHIELD is a medical device that received FDA 510(k) clearance on 1988-03-04. The listed applicant is Laerdal Medical Corp.. The 510(k) number is K880450.

When did RESUSCI PATIENT FACE SHIELD receive FDA 510(k) clearance?

RESUSCI PATIENT FACE SHIELD received FDA 510(k) clearance on 1988-03-04, under 510(k) number K880450.

Who is the listed applicant for RESUSCI PATIENT FACE SHIELD?

The FDA 510(k) record lists Laerdal Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESUSCI PATIENT FACE SHIELD?

The FDA product code for RESUSCI PATIENT FACE SHIELD is BTM.

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Other records listing Laerdal Medical Corp. 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.

K001742RESUSCI INFLATE-A-SHIELD CPR BARRIERK962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDK954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)K954609HEARTSTART 911K950698LSU 2000 PORTABLE SUCTION UNITK933048LAERDAL(TM) POCKET MASK, MODIFICATION

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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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