|
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 | S040 |
Date Received | 07/31/2019 |
Decision Date | 02/14/2020 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes in servicing of the LifePulse HFV model 204 (HFV 204) and Patient Box model 314 (Patient Box 314). |