Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K972970 |
Device Name |
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE |
Applicant |
GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. |
P.O. BOX 1271 |
BUAFFLO,
NY
14240 -1271
|
|
Applicant Contact |
KATHLEEN SELOVER |
Correspondent |
GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. |
P.O. BOX 1271 |
BUAFFLO,
NY
14240 -1271
|
|
Correspondent Contact |
KATHLEEN SELOVER |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 08/11/1997 |
Decision Date | 08/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|