LIFE PULSE HIGH FREQUENCY VENTILATOR
FDA premarket approval P850064/S023 · decided 2015-05-15
Approval details
- PMA number
- P850064
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFE PULSE HIGH FREQUENCY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2013-06-10
- Decision date
- 2015-05-15
- Days to decision
- 704 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- APPROVAL FOR THE CHANGE THE THERMISTOR IN THE PATIENT CIRCUIT USED WITH THE LIFE PULSE HIGH FREQUENCY VENTILATOR.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.