Device Classification Name |
System, X-Ray, Angiographic
|
510(k) Number |
K071619 |
Device Name |
SPY FLUORESCENT IMAGING SYSTEM |
Applicant |
NOVADAQ TECHNOLOGIES, INC. |
2585 SKYMARK AVENUE, STE. 306 |
MISSISSAUGA, ONTARIO,
CA
L4W 4L5
|
|
Applicant Contact |
ALLISON MANNERS |
Correspondent |
NOVADAQ TECHNOLOGIES, INC. |
2585 SKYMARK AVENUE, STE. 306 |
MISSISSAUGA, ONTARIO,
CA
L4W 4L5
|
|
Correspondent Contact |
ALLISON MANNERS |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 06/13/2007 |
Decision Date | 11/09/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|