PMA P890057S020
- Device
- HIGH FREQUENCY OSCILLATING VENTILATOR
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S020
- Product code
- LSZ
- Decision date
- 2012-01-31
- Classification
- Ventilator, High Frequency
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ADHESIVE TO THE WELDED JOINTS OF THE BREATHING CIRCUIT HUB IN THE DEVICE.
Current openFDA PMA Record#
- Device
- HIGH FREQUENCY OSCILLATING VENTILATOR
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S020
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2012-01-31
- Decision code
- APPR
- Date received
- 2011-12-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ADHESIVE TO THE WELDED JOINTS OF THE BREATHING CIRCUIT HUB IN THE DEVICE.