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FDA 510(k)

INFANT WARMER

K-Number: K931529 · 1994-03-11

ApplicantMedix I.C.S.A.
Decision Date1994-03-11
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT WARMER 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 1994-03-11 under 510(k) number K931529. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT WARMER?

INFANT WARMER is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Medix I.C.S.A.. The 510(k) number is K931529.

When did INFANT WARMER receive FDA 510(k) clearance?

INFANT WARMER received FDA 510(k) clearance on 1994-03-11, under 510(k) number K931529.

Who is the listed applicant for INFANT WARMER?

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 INFANT WARMER?

The FDA product code for INFANT WARMER is FMT.

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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/BXK931965MEDIX PHOTOTHERAPY LAMPK920049MEDIX PC-305 NEONATAL INCUBATOR

Related Devices (Code: FMT)

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.

K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc.

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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