Device Classification Name |
Electrocardiograph
|
510(k) Number |
K861359 |
Device Name |
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM |
Applicant |
HEWLETT-PACKARD CO. |
175 WALTHAM ST. |
P.O.BOX 9030 |
WALTHAM,
MA
02254
|
|
Applicant Contact |
NICHOLAS POLY |
Correspondent |
HEWLETT-PACKARD CO. |
175 WALTHAM ST. |
P.O.BOX 9030 |
WALTHAM,
MA
02254
|
|
Correspondent Contact |
NICHOLAS POLY |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 04/10/1986 |
Decision Date | 05/16/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|