PHOTOTHERAPY/PROCEDURE LAMP

Unit, Neonatal Phototherapy

CAVITRON CORP.

The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Phototherapy/procedure Lamp.

Pre-market Notification Details

Device IDK771025
510k NumberK771025
Device Name:PHOTOTHERAPY/PROCEDURE LAMP
ClassificationUnit, Neonatal Phototherapy
Applicant CAVITRON CORP. 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 Received1977-06-08
Decision Date1977-10-25

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