PMA P890057S019

Device: MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR
Applicant: ZOLL Medical Corporation
PMA number: P890057
Supplement: S019
Product code: LSZ
Decision date: 2007-04-25
Classification: Ventilator, High Frequency
Generic name: VENTILATOR, HIGH FREQUENCY
Approval order statement: APPROVAL FOR THE MODIFICATION OF THE BREATHING CIRCUIT TO INCLUDE TWO FILTERS, ONE IN THE INSPIRATORY LIMB AFTER THE GAS SUPPLY LINE AND RELIEVE VALVE AND ANOTHER AT THE EXPIRATORY LIMB BEFORE THE DUMP VALVE.

Current openFDA PMA Record#

Device: MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR
Applicant: ZOLL Medical Corporation
PMA number: P890057
Supplement: S019
Product code: LSZ
Generic name: VENTILATOR, HIGH FREQUENCY
Decision date: 2007-04-25
Decision code: APPR
Date received: 2007-01-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODIFICATION OF THE BREATHING CIRCUIT TO INCLUDE TWO FILTERS, ONE IN THE INSPIRATORY LIMB AFTER THE GAS SUPPLY LINE AND RELIEVE VALVE AND ANOTHER AT THE EXPIRATORY LIMB BEFORE THE DUMP VALVE.