TRUTEK SELECT MODEL TT-1001


Device Classification Name

thermometer, electronic, clinical

510(k) Number K023510
Device Name TRUTEK SELECT MODEL TT-1001
Original Applicant
TRUTEK, INC.
p.o. box 4341
crofton, 
MD 
21114

Original Contact e.j. smith
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 10/21/2002
Decision Date 02/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No