PMA P890057S028

Device: 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator
Applicant: ZOLL Medical Corporation
PMA number: P890057
Supplement: S028
Product code: LSZ
Decision date: 2024-02-20
Classification: Anesthesiology
Generic name: VENTILATOR, HIGH FREQUENCY
Approval order statement: Approval for the new manufacturing location for the 3100 patient circuits tubing, 77273-101 and 772722-102.

Current openFDA PMA Record#

Device: 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator
Applicant: ZOLL Medical Corporation
PMA number: P890057
Supplement: S028
Product code: LSZ
Generic name: VENTILATOR, HIGH FREQUENCY
Decision date: 2024-02-20
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: Approval for the new manufacturing location for the 3100 patient circuits tubing, 77273-101 and 772722-102.