PMA P850064S047

Device: LifePulse High Frequency Ventilator
Applicant: Bunnell, Inc.
PMA number: P850064
Supplement: S047
Product code: LSZ
Decision date: 2022-03-31
Generic name: VENTILATOR, HIGH FREQUENCY
Approval order statement: Change to the current Pneumatics Test Fixture that is used to perform in-process performance tests on the Pneumatics Subassembly (HFV 204) to ensure basic functionality and to make rough adjustments prior to installation of this subassembly into the Life PulseHigh Frequency Ventilator.

Current openFDA PMA Record#

Device: LifePulse High Frequency Ventilator
Applicant: Bunnell, Inc.
PMA number: P850064
Supplement: S047
Product code: LSZ
Generic name: VENTILATOR, HIGH FREQUENCY
Decision date: 2022-03-31
Decision code: OK30
Date received: 2022-03-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the current Pneumatics Test Fixture that is used to perform in-process performance tests on the Pneumatics Subassembly (HFV 204) to ensure basic functionality and to make rough adjustments prior to installation of this subassembly into the Life PulseHigh Frequency Ventilator.