PMA P890057S009
- Device
- MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S009
- Product code
- LSZ
- Decision date
- 1997-07-08
- Classification
- Ventilator, High Frequency
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MANUFACTURING OF THE PATIENT CIRCUIT TO ULTRASONIC WELDING.
Current openFDA PMA Record#
- Device
- MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S009
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 1997-07-08
- Decision code
- APPR
- Date received
- 1997-05-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MANUFACTURING OF THE PATIENT CIRCUIT TO ULTRASONIC WELDING.