LifePulse High Frequency Ventilator
FDA premarket approval P850064/S052 · decided 2024-06-21
Approval details
- PMA number
- P850064
- Supplement
- S052
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LifePulse High Frequency Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2023-07-12
- Decision date
- 2024-06-21
- Days to decision
- 345 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- The site was inspected in April 2024 and the EIR recommendation was VAI. Review of the report and the Firm's response were provided. The recommendation for the inspection is VAI.
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