LifePulse High Frequency Ventilator
FDA premarket approval P850064/S050 · decided 2023-05-31
Approval details
- PMA number
- P850064
- Supplement
- S050
- 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
- 2023-05-10
- Decision date
- 2023-05-31
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Replace the Thermistor Inspection Fixtures with an upgraded design. This change would increase the ease and efficiency of performing incoming inspections of the 3 thermistors (P/N 00234) and 58 thermistors (P/N 00235) which are components in the Patient Circuit used in the LifePulse HFV Systems. The new Inspection Fixtures will not affect the safety or effectiveness of the Patient Circuit or the LifePulse HFV.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.