LIFE PULSE HIGH FREQUENCY VENTILATOR
FDA premarket approval P850064/S017 · decided 2002-09-05
Approval details
- PMA number
- P850064
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFE PULSE HIGH FREQUENCY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2001-04-04
- Decision date
- 2002-09-05
- Days to decision
- 519 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- APPROVAL FOR A NEW PATIENT BOX.
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