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FDA 510(k)

LAERDAL(TM) POCKET MASK, MODIFICATION

K-Number: K933048 · 1993-12-02

ApplicantLaerdal Medical Corp.
Decision Date1993-12-02
Product CodeKGB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LAERDAL(TM) POCKET MASK, MODIFICATION 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 1993-12-02 under 510(k) number K933048. The device is classified under product code KGB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAERDAL(TM) POCKET MASK, MODIFICATION?

LAERDAL(TM) POCKET MASK, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is Laerdal Medical Corp.. The 510(k) number is K933048.

When did LAERDAL(TM) POCKET MASK, MODIFICATION receive FDA 510(k) clearance?

LAERDAL(TM) POCKET MASK, MODIFICATION received FDA 510(k) clearance on 1993-12-02, under 510(k) number K933048.

Who is the listed applicant for LAERDAL(TM) POCKET MASK, MODIFICATION?

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 LAERDAL(TM) POCKET MASK, MODIFICATION?

The FDA product code for LAERDAL(TM) POCKET MASK, MODIFICATION is KGB.

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 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 UNITK896919HEARTSTART 3000

View all 11 devices →

Related Devices (Code: KGB)

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.

K970688POCKET RESCUECheen Houng Ent. Co. , Ltd.K960401ULTIMATE SEALHans Rudolph, Inc.K941336COMBO MASKGam Industries, Inc.K935917CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems PreanalyticK932347COMPACT MASKVital Signs, Inc.K933583NONREBREATHING VALVEHans Rudolph, Inc.

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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