Device Classification Name |
System, Telethermographic (Adjunctive Use)
|
510(k) Number |
K033967 |
FOIA Releasable 510(k) |
K033967
|
Device Name |
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P |
Applicant |
FLIR SYSTEMS |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
FLIR SYSTEMS |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 884.2980
|
Classification Product Code |
|
Date Received | 12/22/2003 |
Decision Date | 03/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|