LifePulse High Frequency Ventilator
FDA premarket approval P850064/S047 · decided 2022-03-31
Approval details
- PMA number
- P850064
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LifePulse High Frequency Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2022-03-07
- Decision date
- 2022-03-31
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Change to the current Pneumatics Test Fixture that is used to perform in-process performance tests on the Pneumatics Subassembly (HFV 204) to ensure basic functionality and to make rough adjustments prior to installation of this subassembly into the Life PulseHigh Frequency Ventilator.
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