PMA P850064S037

Device

Model 203 Life Pulse High Frequency Ventilator

Applicant

Bunnell, Inc.

PMA number

P850064

Supplement

S037

Product code

LSZ

Decision date

2018-10-19

Classification

Ventilator, High Frequency

Generic name

VENTILATOR, HIGH FREQUENCY

Approval order 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 ventilation. The infantsstudied ranged in birth weight from 600 to 3,660 grams and in gestational age from 24 to 38 weeks.

Summary

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