MODIFICATION TO ACCUDEXA BONE DENSITOMETER

Densitometer, Bone

SCHICK TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Modification To Accudexa Bone Densitometer.

Pre-market Notification Details

Device IDK001429
510k NumberK001429
Device Name:MODIFICATION TO ACCUDEXA BONE DENSITOMETER
ClassificationDensitometer, Bone
Applicant SCHICK TECHNOLOGIES, INC. 31-00 47TH AVE. Long Island,  NY  11101
ContactDaniel Michaeli
CorrespondentDaniel Michaeli
SCHICK TECHNOLOGIES, INC. 31-00 47TH AVE. Long Island,  NY  11101
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-05
Decision Date2000-05-26

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