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FDA 510(k)

KACEY DISPOSABLE INFANT HEEL WARMER

K-Number: K934673 · 1994-02-02

ApplicantK & C Medical, Inc.
Decision Date1994-02-02
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KACEY DISPOSABLE INFANT HEEL WARMER is the device name listed in this FDA 510(k) record. The listed applicant is K & C Medical, Inc.. It received FDA 510(k) clearance on 1994-02-02 under 510(k) number K934673. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KACEY DISPOSABLE INFANT HEEL WARMER?

KACEY DISPOSABLE INFANT HEEL WARMER is a medical device that received FDA 510(k) clearance on 1994-02-02. The listed applicant is K & C Medical, Inc.. The 510(k) number is K934673.

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

KACEY DISPOSABLE INFANT HEEL WARMER received FDA 510(k) clearance on 1994-02-02, under 510(k) number K934673.

Who is the listed applicant for KACEY DISPOSABLE INFANT HEEL WARMER?

The FDA 510(k) record lists K & C Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KACEY DISPOSABLE INFANT HEEL WARMER?

The FDA product code for KACEY DISPOSABLE INFANT HEEL WARMER is IMD.

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 K & C Medical, Inc. 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.

K935158KACEY DISPOSABLE GLOVE LINER

Related Devices (Code: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational BiomedicalK163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLCK082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, 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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