Device Classification Name |
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
|
510(k) Number |
K851091 |
Device Name |
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR |
Applicant |
MEDTRONIC VASCULAR |
800 53RD AVENUE, NE |
P.O. BOX 1250 |
MINNEAPOLIS,
MN
55440 -9087
|
|
Applicant Contact |
JOHNSON |
Correspondent |
MEDTRONIC VASCULAR |
800 53RD AVENUE, NE |
P.O. BOX 1250 |
MINNEAPOLIS,
MN
55440 -9087
|
|
Correspondent Contact |
JOHNSON |
Regulation Number | 870.1750
|
Classification Product Code |
|
Date Received | 03/18/1985 |
Decision Date | 04/16/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|