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FDA 510(k)

MEDI-HEAT INFANT HEEL WARMER

K-Number: K032989 · 2003-10-22

ApplicantMediheat, Inc.
Decision Date2003-10-22
Product CodeMPO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MEDI-HEAT INFANT HEEL WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Mediheat, Inc.. It received FDA 510(k) clearance on 2003-10-22 under 510(k) number K032989. The device is classified under product code MPO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-HEAT INFANT HEEL WARMER?

MEDI-HEAT INFANT HEEL WARMER is a medical device that received FDA 510(k) clearance on 2003-10-22. The listed applicant is Mediheat, Inc.. The 510(k) number is K032989.

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

MEDI-HEAT INFANT HEEL WARMER received FDA 510(k) clearance on 2003-10-22, under 510(k) number K032989.

Who is the listed applicant for MEDI-HEAT INFANT HEEL WARMER?

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

What is the FDA product code for MEDI-HEAT INFANT HEEL WARMER?

The FDA product code for MEDI-HEAT INFANT HEEL WARMER is MPO.

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Related Devices (Code: MPO)

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.

K221154Infant Heel WarmerTM; Heel Snuggler®International BiomedicalK151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc.K103549DENOVO TEDDY GEL INFANT HEEL WARMERDenovo Products, LLCK053254INFANT HEEL WARMER BY INTCOShanghai Intco Medical Supply Co., Ltd.K040856RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMERRapid Aid , Ltd.K040044HEEL SNUGGLER, MODEL 99047Respironics, 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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