OHIO 3000 INFANT WARMER SYSTEM

Warmer, Infant Radiant

OHIO MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio 3000 Infant Warmer System.

Pre-market Notification Details

Device IDK840857
510k NumberK840857
Device Name:OHIO 3000 INFANT WARMER SYSTEM
ClassificationWarmer, Infant Radiant
Applicant OHIO MEDICAL PRODUCTS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFMT  
CFR Regulation Number880.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-24
Decision Date1984-03-23

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