LifePulse High Frequency Ventilator
FDA premarket approval P850064/S036 · decided 2018-04-27
Approval details
- PMA number
- P850064
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LifePulse High Frequency Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2018-01-29
- Decision date
- 2018-04-27
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for adding a Funnel shape to the machine end of the 5.5 mm LifePort Adapter via the molding process. The disposable LifePort Adapters were approved for use with the LifePulse High Frequency Ventilator Model 204 in 1995.
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