MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
FDA premarket approval P890057/S007 · decided 1996-12-20
Approval details
- PMA number
- P890057
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 1996-02-26
- Decision date
- 1996-12-20
- Days to decision
- 298 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- APPROVAL FOR REPLACEMENT FLEXIBLE TUBING AND HEATED WIRE ACCESSORIES AND IS INDICATED FOR USE WITH MDOE 3100 AND 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR.
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