Model 203 Life Pulse High Frequency Ventilator
FDA premarket approval P850064/S037 · decided 2018-10-19
Approval details
- PMA number
- P850064
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Model 203 Life Pulse High Frequency Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2018-09-20
- Decision date
- 2018-10-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- The LifePulse High Frequency Ventilator is indicated for use in ventilating critically ill infants with pulmonary interstitial emphysema (PIE). Infants studied ranged in birth weight from 750 to 3,529 grams and in gestational age from 24 to 41 weeks. The LifePulse High Frequency Ventilator is also indicated for use in ventilating critically illinfants with respiratory distress syndrome (RDS) complicated by pulmonary air leaks who are, in the opinion of their physicians, failing on conventional v
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