Airborne Phototherapy Light

Unit, Neonatal Phototherapy

INTERNATIONAL BIOMEDICAL

The following data is part of a premarket notification filed by International Biomedical with the FDA for Airborne Phototherapy Light.

Pre-market Notification Details

Device IDK160238
510k NumberK160238
Device Name:Airborne Phototherapy Light
ClassificationUnit, Neonatal Phototherapy
Applicant INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin,  TX  78754
ContactAmy Pieper
CorrespondentAmy Pieper
INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin,  TX  78754
Product CodeLBI  
CFR Regulation Number880.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-01
Decision Date2016-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00868406000075 K160238 000

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