Device Classification Name |
Camera, X-Ray, Fluorographic, Cine Or Spot
|
510(k) Number |
K945580 |
Device Name |
DSP OPTION |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Applicant Contact |
ROBERT L TUROCY |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Correspondent Contact |
ROBERT L TUROCY |
Regulation Number | 892.1620
|
Classification Product Code |
|
Date Received | 11/14/1994 |
Decision Date | 01/30/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|