HOME BILI LIGHTS-MODEL 100

Unit, Neonatal Phototherapy

PHYSICIAN ENGINEERED PRODUCTS, INC.

The following data is part of a premarket notification filed by Physician Engineered Products, Inc. with the FDA for Home Bili Lights-model 100.

Pre-market Notification Details

Device IDK850599
510k NumberK850599
Device Name:HOME BILI LIGHTS-MODEL 100
ClassificationUnit, Neonatal Phototherapy
Applicant PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids,  MN  56470
ContactRose
CorrespondentRose
PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids,  MN  56470
Product CodeLBI  
CFR Regulation Number880.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-15
Decision Date1985-06-17

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