Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K023510 |
Device Name |
TRUTEK SELECT MODEL TT-1001 |
Applicant |
TRUTEK, INC. |
P.O. BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
N.E. DEVINE |
Regulation Number | 880.2910
|
Classification Product Code |
|
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
|
|
|