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FDA 510(k)

RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER

K-Number: K003335 · 2000-11-17

ApplicantHill-Rom Air-Shields
Decision Date2000-11-17
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom Air-Shields. It received FDA 510(k) clearance on 2000-11-17 under 510(k) number K003335. 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 RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER?

RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER is a medical device that received FDA 510(k) clearance on 2000-11-17. The listed applicant is Hill-Rom Air-Shields. The 510(k) number is K003335.

When did RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER receive FDA 510(k) clearance?

RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER received FDA 510(k) clearance on 2000-11-17, under 510(k) number K003335.

Who is the listed applicant for RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER?

The FDA 510(k) record lists Hill-Rom Air-Shields as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER?

The FDA product code for RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER is FMT.

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 Hill-Rom Air-Shields 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.

K021622HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103K001242ISOLETTE INFANT INCUBATOR, MODEL C2HSK001019TI500 GLOBE-TROTTER TRANSPORT SYSTEMK993051VERSALET 7700 CARE CENTER, MODEL # 7700

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

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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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