Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K092713 |
Device Name |
SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM |
Applicant |
TRANSAMERICAN MEDICAL IMAGING |
965 WEST 325 NORTH |
LINDON,
UT
84042
|
|
Applicant Contact |
ROBERT H WOODWARD |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 09/03/2009 |
Decision Date | 07/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|