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FDA 510(k)

PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US

K-Number: K031470 · 2003-06-05

ApplicantTyco Healthcare Nancy
Decision Date2003-06-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare Nancy. It received FDA 510(k) clearance on 2003-06-05 under 510(k) number K031470. 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 PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US?

PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US is a medical device that received FDA 510(k) clearance on 2003-06-05. The listed applicant is Tyco Healthcare Nancy. The 510(k) number is K031470.

When did PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US receive FDA 510(k) clearance?

PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US received FDA 510(k) clearance on 2003-06-05, under 510(k) number K031470.

Who is the listed applicant for PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US?

The FDA 510(k) record lists Tyco Healthcare Nancy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US?

The FDA product code for PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tyco Healthcare Nancy 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.

K020886PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US

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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