Device Classification Name |
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
|
510(k) Number |
K983196 |
Device Name |
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) |
Applicant |
TZ MEDICAL, INC. |
15858 S.W. UPPER BOONES FERRY |
RD. |
LAKE OSWEGO,
OR
97035
|
|
Applicant Contact |
BYRON ZAHLER |
Correspondent |
TZ MEDICAL, INC. |
15858 S.W. UPPER BOONES FERRY |
RD. |
LAKE OSWEGO,
OR
97035
|
|
Correspondent Contact |
BYRON ZAHLER |
Regulation Number | 870.5550
|
Classification Product Code |
|
Date Received | 09/11/1998 |
Decision Date | 09/15/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|