- Device
- MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S007
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 1996-12-20
- Decision code
- APPR
- Date received
- 1996-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REPLACEMENT FLEXIBLE TUBING AND HEATED WIRE ACCESSORIES AND IS INDICATED FOR USE WITH MDOE 3100 AND 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR.