| Device Classification Name |
Blood Pressure Cuff
|
| 510(k) Number |
K905101 |
| Device Name |
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF |
| Applicant |
| Hewlett-Packard Co. |
| 3000 Minuteman Rd. |
|
Andover,
MA
01810 -1085
|
|
| Applicant Contact |
DONALD A GUTHRIE |
| Correspondent |
| Hewlett-Packard Co. |
| 3000 Minuteman Rd. |
|
Andover,
MA
01810 -1085
|
|
| Correspondent Contact |
DONALD A GUTHRIE |
| Regulation Number | 870.1120 |
| Classification Product Code |
|
| Date Received | 11/13/1990 |
| Decision Date | 12/20/1990 |
| 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
|
|
|