PMA P890057S025
- Device
- Model 3100A/B High Frequency Oscillatory Ventilator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S025
- Product code
- LSZ
- Decision date
- 2022-07-22
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- Approval for modifications to the material of construction of your 3100A/B bellows water trap assembly.
Current openFDA PMA Record#
- Device
- Model 3100A/B High Frequency Oscillatory Ventilator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S025
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2022-07-22
- Decision code
- APPR
- Date received
- 2022-04-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the material of construction of your 3100A/B bellows water trap assembly.