NEONATAL PHOTOTHERAPY UNIT

Unit, Neonatal Phototherapy

OHIO MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Neonatal Phototherapy Unit.

Pre-market Notification Details

Device IDK802702
510k NumberK802702
Device Name:NEONATAL PHOTOTHERAPY UNIT
ClassificationUnit, Neonatal Phototherapy
Applicant OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLBI  
CFR Regulation Number880.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-03
Decision Date1980-12-10

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