Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K052908 |
Device Name |
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 |
Applicant |
Infraredx, Inc. |
34 THIRD AVE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
Nandini Murthy |
Correspondent |
Infraredx, Inc. |
34 THIRD AVE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
Nandini Murthy |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 10/14/2005 |
Decision Date | 06/23/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|