INTRA SKAN DC


Device Classification Name

unit, x-ray, extraoral with timer

510(k) Number K103579
Device Name INTRA SKAN DC
Applicant
SKANRAY TECHNOLOGIES
78 a&b, hootagalli industrial
area
mysore, 

IN

570017

Applicant Contact parasuramappa belur
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 12/06/2010
Decision Date 03/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No