| Device Classification Name |
Monitor, Electric For Gravity Flow Infusion Systems
|
| 510(k) Number |
K893693 |
| Device Name |
H.U. I.V. DROP COUNTER |
| Applicant |
| Li-Lien Corp. |
| C/O Tridec Corporation |
| 1590 Old Oakland Rd. Suite B 109 |
|
San Jose,
CA
95131
|
|
| Applicant Contact |
SIMON FUNG |
| Correspondent |
| Li-Lien Corp. |
| C/O Tridec Corporation |
| 1590 Old Oakland Rd. Suite B 109 |
|
San Jose,
CA
95131
|
|
| Correspondent Contact |
SIMON FUNG |
| Regulation Number | 880.2420 |
| Classification Product Code |
|
| Date Received | 05/16/1989 |
| Decision Date | 10/27/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|