LifePulse High Frequency Ventilator
FDA premarket approval P850064/S053 · decided 2023-12-28
Approval details
- PMA number
- P850064
- Supplement
- S053
- 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
- 2023-09-29
- Decision date
- 2023-12-28
- 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 the filter element that is included in the Camozzi Filter Assembly. The filter element, made from HDPE, has gone from a white with pink speckles color to a light blue color. All other specifications remain the same and the color change is being made to differentiate between filter elements.
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