9170, 1170

System, X-ray, Mobile

DYNARAD CORP.

The following data is part of a premarket notification filed by Dynarad Corp. with the FDA for 9170, 1170.

Pre-market Notification Details

Device IDK932354
510k NumberK932354
Device Name:9170, 1170
ClassificationSystem, X-ray, Mobile
Applicant DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park,  NY  11729
ContactRaymond Manez
CorrespondentRaymond Manez
DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park,  NY  11729
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-13
Decision Date1993-07-23

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