Device Classification Name |
Catheter, Electrode Recording, Or Probe, Electrode Recording
More FDA Info for this Device |
510(K) Number |
K960542 |
Device Name |
Catheter, Electrode Recording, Or Probe, Electrode Recording |
Applicant |
BIOSENSE, LTD.
EINSTEIN BUILDING, ETGAR ST.
NEW INDUSTRIAL AREA, POB 297
TIRAT HACARMEL, HAIFA 39101 IL
Other 510(k) Applications for this Company
|
Contact |
SUSAN J ZACHMAN
Other 510(k) Applications for this Contact |
Regulation Number |
870.1220
More FDA Info for this Regulation Number |
Classification Product Code |
DRF
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/07/1996 |
Decision Date |
04/15/1996 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|