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FDA 510(k)

INFANT HEEL WARMER

K-Number: K950680 · 1995-08-23

ApplicantBaxter Healthcare Corp
Decision Date1995-08-23
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

INFANT HEEL WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1995-08-23 under 510(k) number K950680. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INFANT HEEL WARMER?

INFANT HEEL WARMER is a medical device that received FDA 510(k) clearance on 1995-08-23. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K950680.

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

INFANT HEEL WARMER received FDA 510(k) clearance on 1995-08-23, under 510(k) number K950680.

Who is the listed applicant for INFANT HEEL WARMER?

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

What is the FDA product code for INFANT HEEL WARMER?

The FDA product code for INFANT HEEL WARMER is IMD.

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Other records listing Baxter Healthcare Corp as applicant

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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

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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