LIFE PULSE HIGH FREQUENCY VENTILATOR, MODELS 203 AND 203A
FDA premarket approval P850064/S018 · decided 2010-08-20
Approval details
- PMA number
- P850064
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFE PULSE HIGH FREQUENCY VENTILATOR, MODELS 203 AND 203A
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2010-02-22
- Decision date
- 2010-08-20
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- APPROVAL FOR A MODIFICATION TO THE VENTILATOR SOFTWARE.
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