AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY

Unit, X-ray, Extraoral With Timer

SKANRAY TECHNOLOGIES

The following data is part of a premarket notification filed by Skanray Technologies with the FDA for Air Techniques High Frequency Intra-oral X-ray.

Pre-market Notification Details

Device IDK111330
510k NumberK111330
Device Name:AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
ClassificationUnit, X-ray, Extraoral With Timer
Applicant SKANRAY TECHNOLOGIES PLOT 15-17 HEBBAL INDUSTRIAL AREA Mysore,  IN 570016
ContactParasuramappa Belur
CorrespondentMorten S Christensen
UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose,  CA  95131 -1230
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-05-11
Decision Date2011-05-27
Summary:summary

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