PMA P850064S044
- Device
- Life Pulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S044
- Product code
- LSZ
- Decision date
- 2021-02-24
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- Change to the test equipment used for electrical safety testing during in-house servicing of the Life Pulse High Frequency Ventilator Model 203.
Current openFDA PMA Record#
- Device
- Life Pulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S044
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2021-02-24
- Decision code
- OK30
- Date received
- 2021-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the test equipment used for electrical safety testing during in-house servicing of the Life Pulse High Frequency Ventilator Model 203.