TITRATOR{TM} MODEL 10K
FDA premarket approval P860035/S001 · decided 1989-05-01
Approval details
- PMA number
- P860035
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TITRATOR{TM} MODEL 10K
- Generic name
- CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE
- Applicant
- Ivac Corporation
- Date received
- 1989-03-15
- Decision date
- 1989-05-01
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- LSX
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- San Diego, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS (K946168) | Ivac Corporation | 1996-03-21 |