Device Classification Name |
Stretcher, Wheeled
|
510(k) Number |
K923730 |
Device Name |
MODEL 561 C-ARM PROCEDURES STRETCHER |
Applicant |
MIDMARK CORP. |
60 VISTA DR. |
P.O. BOX 286 |
VERSAILLES,
OH
45380
|
|
Applicant Contact |
BRADLEY K SEIDEN |
Correspondent |
MIDMARK CORP. |
60 VISTA DR. |
P.O. BOX 286 |
VERSAILLES,
OH
45380
|
|
Correspondent Contact |
BRADLEY K SEIDEN |
Regulation Number | 880.6910 |
Classification Product Code |
|
Date Received | 07/27/1992 |
Decision Date | 02/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|