HIGH FREQUENCY OSCILLATORY VENTILATOR
FDA premarket approval P890057/S015 · decided 2002-01-08
Approval details
- PMA number
- P890057
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIGH FREQUENCY OSCILLATORY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 2001-08-09
- Decision date
- 2002-01-08
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- APPROVAL OF A MODIFICATION TO THE DESIGN OF THE DRIVER DIAPHRAGM IN THE DEVICE.
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