Device Classification Name |
pulse-generator, pacemaker, external
|
510(k) Number |
K896352 |
Device Name |
MODEL EC4542G MINIATURE |
Applicant |
PACE MEDICAL |
391 TOTTEN POND RD. |
WALTHAM,
MA
02451
|
|
Applicant Contact |
ROBERT C MACE |
Correspondent |
PACE MEDICAL |
391 TOTTEN POND RD. |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
ROBERT C MACE |
Regulation Number | 870.3600
|
Classification Product Code |
|
Date Received | 11/06/1989 |
Decision Date | 01/24/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|