PMA P890057S027

Device: 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator
Applicant: ZOLL Medical Corporation
PMA number: P890057
Supplement: S027
Product code: LSZ
Decision date: 2024-11-15
Classification: Anesthesiology
Generic name: VENTILATOR, HIGH FREQUENCY
Approval order statement: The material change made to a component on 3100 HFOV pressure sense line as part of the patient circuit has been reviewed and is acceptable.

Current openFDA PMA Record#

Device: 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator
Applicant: ZOLL Medical Corporation
PMA number: P890057
Supplement: S027
Product code: LSZ
Generic name: VENTILATOR, HIGH FREQUENCY
Decision date: 2024-11-15
Decision code: APPR
Date received: 2023-07-03
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The material change made to a component on 3100 HFOV pressure sense line as part of the patient circuit has been reviewed and is acceptable.