DigiX FDX

System, X-ray, Stationary

Allengers Medical Systems Limited

The following data is part of a premarket notification filed by Allengers Medical Systems Limited with the FDA for Digix Fdx.

Pre-market Notification Details

Device IDK223060
510k NumberK223060
Device Name:DigiX FDX
ClassificationSystem, X-ray, Stationary
Applicant Allengers Medical Systems Limited FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali,  IN 140507
ContactSanjeev K Marjara
CorrespondentSanjeev K Marjara
Allengers Medical Systems Limited FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali,  IN 140507
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-30
Decision Date2022-10-26

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