MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR
FDA premarket approval P890057/S019 · decided 2007-04-25
Approval details
- PMA number
- P890057
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 2007-01-03
- Decision date
- 2007-04-25
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- APPROVAL FOR THE MODIFICATION OF THE BREATHING CIRCUIT TO INCLUDE TWO FILTERS, ONE IN THE INSPIRATORY LIMB AFTER THE GAS SUPPLY LINE AND RELIEVE VALVE AND ANOTHER AT THE EXPIRATORY LIMB BEFORE THE DUMP VALVE.
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