Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K121239 |
Device Name |
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE |
Applicant |
OPTOACOUSTICS LTD |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
OPTOACOUSTICS LTD |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 04/24/2012 |
Decision Date | 05/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|