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FDA 510(k)

LAERDAL POCKET MASK

K-Number: K861401 · 1986-05-21

ApplicantLaerdal Medical Corp.
Decision Date1986-05-21
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LAERDAL POCKET MASK 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 1986-05-21 under 510(k) number K861401. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAERDAL POCKET MASK?

LAERDAL POCKET MASK is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Laerdal Medical Corp.. The 510(k) number is K861401.

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

LAERDAL POCKET MASK received FDA 510(k) clearance on 1986-05-21, under 510(k) number K861401.

Who is the listed applicant for LAERDAL POCKET MASK?

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 POCKET MASK?

The FDA product code for LAERDAL POCKET MASK is CBP.

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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: CBP)

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.

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou)K173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare LimitedK171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. Co., Ltd.

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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