MINXRAY, MODEL HF120/60H POWERPLUS

System, X-ray, Mobile

MINXRAY, INC.

The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Minxray, Model Hf120/60h Powerplus.

Pre-market Notification Details

Device IDK040046
510k NumberK040046
Device Name:MINXRAY, MODEL HF120/60H POWERPLUS
ClassificationSystem, X-ray, Mobile
Applicant MINXRAY, INC. P.O. BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
MINXRAY, INC. P.O. BOX 7007 Deerfield,  IL  60015
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-12
Decision Date2004-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00861050000309 K040046 000
00858846007024 K040046 000

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