LIFE PULSE HIGH FREQUENCY VENTILATOR
FDA premarket approval P850064/S033 · decided 2016-08-18
Approval details
- PMA number
- P850064
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIFE PULSE HIGH FREQUENCY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2016-07-22
- Decision date
- 2016-08-18
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Change to the Ultrasonic Welding Process used in fabrication of the Cartridge of the Patient Circuit.
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