PMA P850064

Device: LifePulse High Frequency Ventilator (LifePulse HFV) Model 204
Applicant: Bunnell, Inc.
PMA number: P850064
Supplement: S047
Product code: LSZ
Decision date: 2026-05-07
Generic name: VENTILATOR, HIGH FREQUENCY
Approval order statement: This is a 30-DN to provide the change in power cord testing as a result of a CAPA investigation into a miswiring of one single power cord. the testing is adequate to test the incoming inspection for cross-wired power cords and not as a complete safety check.

Current openFDA PMA Record#

Device: LifePulse High Frequency Ventilator (LifePulse HFV) Model 204
Applicant: Bunnell, Inc.
PMA number: P850064
Supplement: S058
Product code: LSZ
Generic name: VENTILATOR, HIGH FREQUENCY
Decision date: 2026-05-07
Decision code: OK30
Date received: 2026-04-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: This is a 30-DN to provide the change in power cord testing as a result of a CAPA investigation into a miswiring of one single power cord. the testing is adequate to test the incoming inspection for cross-wired power cords and not as a complete safety check.