TRIMODE SP DENTAL INTRA ORAL X-RAY

Unit, X-ray, Intraoral

TEMPO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Tempo Technology, Inc. with the FDA for Trimode Sp Dental Intra Oral X-ray.

Pre-market Notification Details

Device IDK896963
510k NumberK896963
Device Name:TRIMODE SP DENTAL INTRA ORAL X-RAY
ClassificationUnit, X-ray, Intraoral
Applicant TEMPO TECHNOLOGY, INC. ROUTE 1, DOWELL RD. Columbia City,  IN  46725
ContactChristopher E Dare
CorrespondentChristopher E Dare
TEMPO TECHNOLOGY, INC. ROUTE 1, DOWELL RD. Columbia City,  IN  46725
Product CodeEAP  
CFR Regulation Number872.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-15
Decision Date1990-01-22

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