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FDA 510(k)

MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2

K-Number: K993584 · 2000-03-07

ApplicantNellcor Puritan Bennett France Dvpt.
Decision Date2000-03-07
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett France Dvpt.. It received FDA 510(k) clearance on 2000-03-07 under 510(k) number K993584. 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 MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2?

MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 is a medical device that received FDA 510(k) clearance on 2000-03-07. The listed applicant is Nellcor Puritan Bennett France Dvpt.. The 510(k) number is K993584.

When did MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 receive FDA 510(k) clearance?

MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 received FDA 510(k) clearance on 2000-03-07, under 510(k) number K993584.

Who is the listed applicant for MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2?

The FDA 510(k) record lists Nellcor Puritan Bennett France Dvpt. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2?

The FDA product code for MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 is BZD.

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 Nellcor Puritan Bennett France Dvpt. 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.

K991150NELLCOR PURITAN BENNETT, GOODKNIGHT 418G

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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