PMA P890057S018
- Device
- MODEL 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV)
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S018
- Product code
- LSZ
- Decision date
- 2005-03-10
- Classification
- Ventilator, High Frequency
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE HEAT AND FILTER ON THE EXHALED GAS LIMB OF THE EXISTING PATIENT CIRCUIT.
Current openFDA PMA Record#
- Device
- MODEL 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV)
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S018
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2005-03-10
- Decision code
- APPR
- Date received
- 2004-12-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE HEAT AND FILTER ON THE EXHALED GAS LIMB OF THE EXISTING PATIENT CIRCUIT.