OP300


Device Classification Name

x-ray, tomography, computed, dental

510(k) Number K122018
Device Name OP300
Applicant
PALODEX GROUP OY
nahkelantie 160
tuusula, 

FI

04300

Applicant Contact matti tulikoura
Correspondent
PALODEX GROUP OY
nahkelantie 160
tuusula, 

FI

04300

Correspodent Contact matti tulikoura
Regulation Number 892.1750
Classification Product Code
OAS  
Date Received 07/10/2012
Decision Date 12/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No