Device Classification Name |
Transducer, Blood-Pressure, Extravascular
|
510(k) Number |
K860681 |
Device Name |
DISPOSABLE FLUSH DEVICE |
Applicant |
HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1085
|
|
Applicant Contact |
THOMAS P STEPHENS |
Correspondent |
HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1085
|
|
Correspondent Contact |
THOMAS P STEPHENS |
Regulation Number | 870.2850 |
Classification Product Code |
|
Date Received | 02/25/1986 |
Decision Date | 06/17/1986 |
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
|
|
|