MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY

Image-intensified Fluoroscopic X-ray System, Mobile

TEMPO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Tempo Technology, Inc. with the FDA for Model 90p Portable Medical Diagnostic X-ray.

Pre-market Notification Details

Device IDK934700
510k NumberK934700
Device Name:MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant TEMPO TECHNOLOGY, INC. 2090 W. DOWELL RD. Columbia City,  IN  46725
ContactChristopher E Dare
CorrespondentChristopher E Dare
TEMPO TECHNOLOGY, INC. 2090 W. DOWELL RD. Columbia City,  IN  46725
Product CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-30
Decision Date1994-03-16
Summary:summary

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