Device Classification Name |
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
|
510(k) Number |
K873402 |
Device Name |
ZOLL NTP-1200 PACER/DEFIBRILLATOR |
Applicant |
ZMI CORP. |
325 VASSAR ST. |
CAMBRIDGE,
MA
02139
|
|
Applicant Contact |
PAUL A LEVESQUE |
Correspondent |
ZMI CORP. |
325 VASSAR ST. |
CAMBRIDGE,
MA
02139
|
|
Correspondent Contact |
PAUL A LEVESQUE |
Regulation Number | 870.5550
|
Classification Product Code |
|
Date Received | 08/24/1987 |
Decision Date | 11/23/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|