LifePulse High Frequency Ventilator
FDA premarket approval P850064/S043 · decided 2020-11-25
Approval details
- PMA number
- P850064
- Supplement
- S043
- 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
- 2020-10-29
- Decision date
- 2020-11-25
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Change in the manufacturing process to add another Ultrasonic Welder Configuration for use in their Patient Circuit assembly.
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