PMA P890057

Device: MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
Applicant: ZOLL Medical Corporation
PMA number: P890057
Supplement: S025
Product code: LSZ
Decision date: 2025-07-23
Generic name: VENTILATOR, HIGH FREQUENCY
Approval order statement: for a change in the raw material base resin for the 772722-102 pressure sense line Flex, circuit 71.0 LG, used in the 3100 Series Ventilators Patient Circuit connectors.

Current openFDA PMA Record#

Device: MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
Applicant: ZOLL Medical Corporation
PMA number: P890057
Supplement: S029
Product code: LSZ
Generic name: VENTILATOR, HIGH FREQUENCY
Decision date: 2025-07-23
Decision code: APPR
Date received: 2025-04-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: for a change in the raw material base resin for the 772722-102 pressure sense line Flex, circuit 71.0 LG, used in the 3100 Series Ventilators Patient Circuit connectors.