Device Classification Name |
Electrocardiograph
|
510(k) Number |
K974746 |
Device Name |
M1765A ECG MANAGER |
Applicant |
HEWLETT-PACKARD CO. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
JAMES R VEALE |
Correspondent |
HEWLETT-PACKARD CO. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
JAMES R VEALE |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 12/19/1997 |
Decision Date | 03/18/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|