|
Device | LifePulse High Frequency Ventilator |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | BUNNELL, INC. 436 LAWNDALE DR. SALT LAKE CITY, UT 84115 |
PMA Number | P850064 |
Supplement Number | S049 |
Date Received | 01/06/2023 |
Decision Date | 02/06/2023 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Notice of Change to the Patient Box Burn-In Fixture used during manufacturing and servicing of the LifePulse High Ventilator, specifically the Patient Box. The Patient Box Burn-In Fixture is used to burn in the Patient Boxes when a ventilator is not being burned-in at the same time. |