TITRATOR MODEL 10K
FDA premarket approval P860035 · decided 1987-12-17
Approval details
- PMA number
- P860035
- Trade name
- TITRATOR MODEL 10K
- Generic name
- CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE
- Applicant
- Ivac Corporation
- Date received
- 1986-08-21
- Decision date
- 1987-12-17
- Days to decision
- 483 days
- Decision code
- APPR
- Product code
- LSX
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- San Diego, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS (K946168) | Ivac Corporation | 1996-03-21 |