MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR
FDA premarket approval P850064/S031 · decided 2016-05-24
Approval details
- PMA number
- P850064
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2016-02-24
- Decision date
- 2016-05-24
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for changing the screw material in the Patient Box model 314 of the Life Pulse High Frequency Ventilator.
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