PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206


information about

Device Classification Name

accelerator, linear, medical

510(k) Number K002444
Device Name PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
Original Applicant
SUN NUCLEAR CORP.
425-a pineda court
melbourne, 
FL 
32940

Original Contact thomas l powers
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 08/09/2000
Decision Date 10/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No