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FDA 510(k)

MEDIX PC-305 NEONATAL INCUBATOR

K-Number: K920049 · 1993-05-21

ApplicantMedix I.C.S.A.
Decision Date1993-05-21
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDIX PC-305 NEONATAL INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medix I.C.S.A.. It received FDA 510(k) clearance on 1993-05-21 under 510(k) number K920049. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIX PC-305 NEONATAL INCUBATOR?

MEDIX PC-305 NEONATAL INCUBATOR is a medical device that received FDA 510(k) clearance on 1993-05-21. The listed applicant is Medix I.C.S.A.. The 510(k) number is K920049.

When did MEDIX PC-305 NEONATAL INCUBATOR receive FDA 510(k) clearance?

MEDIX PC-305 NEONATAL INCUBATOR received FDA 510(k) clearance on 1993-05-21, under 510(k) number K920049.

Who is the listed applicant for MEDIX PC-305 NEONATAL INCUBATOR?

The FDA 510(k) record lists Medix I.C.S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIX PC-305 NEONATAL INCUBATOR?

The FDA product code for MEDIX PC-305 NEONATAL INCUBATOR is FMZ.

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 Medix I.C.S.A. 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.

K103735MEDILED MINIK083179MEDILED PHOTOTHERAPY LAMPK070291MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BXK931529INFANT WARMERK931965MEDIX PHOTOTHERAPY LAMP

Related Devices (Code: FMZ)

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.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device 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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