Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K771360 |
Device Name |
ECG SCOPE MODEL 7833 |
Applicant |
HEWLETT-PACKARD CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HEWLETT-PACKARD CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.2300 |
Classification Product Code |
|
Date Received | 07/25/1977 |
Decision Date | 08/04/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|