Device Classification Name |
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
|
510(k) Number |
K911956 |
Device Name |
ZOLL PD-1400 PACER/DEFIBRILLATOR |
Applicant |
ZMI CORP. |
500 WEST CUMMINGS PARK |
WOBURN,
MA
01801
|
|
Applicant Contact |
ALBERT T KELLEY |
Correspondent |
ZMI CORP. |
500 WEST CUMMINGS PARK |
WOBURN,
MA
01801
|
|
Correspondent Contact |
ALBERT T KELLEY |
Regulation Number | 870.5550
|
Classification Product Code |
|
Date Received | 05/02/1991 |
Decision Date | 07/31/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|