CHROMOPHARE D 530 LDR SURGICAL LIGHT

Light, Surgical, Ceiling Mounted

BERCHTOLD HOLDING GMBH

The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Chromophare D 530 Ldr Surgical Light.

Pre-market Notification Details

Device IDK990656
510k NumberK990656
Device Name:CHROMOPHARE D 530 LDR SURGICAL LIGHT
ClassificationLight, Surgical, Ceiling Mounted
Applicant BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen,  DE D-78532
ContactWolfram K Hill
CorrespondentWolfram K Hill
BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen,  DE D-78532
Product CodeFSY  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-01
Decision Date1999-07-20
Summary:summary

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