SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K021360
Device Name SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
Original Applicant
MED-TEC,INC.
1401 8th st. s.e.
p.o. box 320
orange city, 
IA 
51041

Original Contact donald f riibe
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 04/30/2002
Decision Date 06/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No