Device Classification Name |
System, Telethermographic (Adjunctive Use)
|
510(k) Number |
K003130 |
Device Name |
REGUTHERM 952 THERMOGRAPHIC SYSTEM |
Applicant |
SIE-MED, INC. |
11902 SIMPSON RD. |
CLARKSVILLE,
MD
21029
|
|
Applicant Contact |
CHARLES H KYPER |
Correspondent |
SIE-MED, INC. |
11902 SIMPSON RD. |
CLARKSVILLE,
MD
21029
|
|
Correspondent Contact |
CHARLES H KYPER |
Regulation Number | 884.2980
|
Classification Product Code |
|
Date Received | 10/06/2000 |
Decision Date | 02/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|