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FDA 510(k)

DENOVO TEDDY GEL INFANT HEEL WARMER

K-Number: K103549 · 2011-04-08

ApplicantDenovo Products, LLC
Decision Date2011-04-08
Product CodeMPO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DENOVO TEDDY GEL INFANT HEEL WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Denovo Products, LLC. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K103549. 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 DENOVO TEDDY GEL INFANT HEEL WARMER?

DENOVO TEDDY GEL INFANT HEEL WARMER is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Denovo Products, LLC. The 510(k) number is K103549.

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

DENOVO TEDDY GEL INFANT HEEL WARMER received FDA 510(k) clearance on 2011-04-08, under 510(k) number K103549.

Who is the listed applicant for DENOVO TEDDY GEL INFANT HEEL WARMER?

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

What is the FDA product code for DENOVO TEDDY GEL INFANT HEEL WARMER?

The FDA product code for DENOVO TEDDY GEL 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.K053254INFANT HEEL WARMER BY INTCOShanghai Intco Medical Supply Co., Ltd.K040856RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMERRapid Aid , Ltd.K040044HEEL SNUGGLER, MODEL 99047Respironics, Inc.K032989MEDI-HEAT INFANT HEEL WARMERMediheat, 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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