MEDI-HEAT INFANT HEEL WARMER— 510(k) K032989

Substantially Equivalent

Mediheat, Inc.

FDA 510(k) clearance K032989 for MEDI-HEAT INFANT HEEL WARMER, Substantially Equivalent on 2003-10-22. Applicant: Mediheat, Inc.. Device class: 1.

Clearance details

Applicant: Mediheat, Inc.
Product code: Code MPO
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 2003-09-24
Decision date: 2003-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dalton, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.