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FDA 510(k)

GOODKNIGHT 425, MODELM-114500-00

K-Number: K041819 · 2004-07-22

ApplicantMallinckrodt Developpement France
Decision Date2004-07-22
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GOODKNIGHT 425, MODELM-114500-00 is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Developpement France. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K041819. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOODKNIGHT 425, MODELM-114500-00?

GOODKNIGHT 425, MODELM-114500-00 is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is Mallinckrodt Developpement France. The 510(k) number is K041819.

When did GOODKNIGHT 425, MODELM-114500-00 receive FDA 510(k) clearance?

GOODKNIGHT 425, MODELM-114500-00 received FDA 510(k) clearance on 2004-07-22, under 510(k) number K041819.

Who is the listed applicant for GOODKNIGHT 425, MODELM-114500-00?

The FDA 510(k) record lists Mallinckrodt Developpement France as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOODKNIGHT 425, MODELM-114500-00?

The FDA product code for GOODKNIGHT 425, MODELM-114500-00 is BZD.

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Other records listing Mallinckrodt Developpement France 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.

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical 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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