LIFE PULSE HIGH FREQUENCY JET VENTILATOR
FDA premarket approval P850064/S009 · decided 1993-04-02
Approval details
- PMA number
- P850064
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFE PULSE HIGH FREQUENCY JET VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 1992-11-27
- Decision date
- 1993-04-02
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
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