Device Classification Name |
system, telethermographic (adjunctive use)
|
510(k) Number |
K073581 |
Device Name |
ICI P AND S SERIES IR CAMERAS |
Applicant |
TEXAS INFRARED |
1705 S. CAPITAL OF TEXAS HWY |
SUITE 500 |
AUSTIN,
TX
78746
|
|
Applicant Contact |
IAN P GORDON |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 884.2980
|
Classification Product Code |
|
Date Received | 12/20/2007 |
Decision Date | 07/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|