MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.
FDA premarket approval P890057/S003 · decided 1995-09-15
Approval details
- PMA number
- P890057
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 1992-06-29
- Decision date
- 1995-09-15
- Days to decision
- 1173 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
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