MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
FDA premarket approval P890034/S001 · decided 1993-09-10
Approval details
- PMA number
- P890034
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Covidien
- Date received
- 1993-08-12
- Decision date
- 1993-09-10
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Boulder, CO
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