|
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 | S043 |
Date Received | 10/29/2020 |
Decision Date | 11/25/2020 |
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 Change in the manufacturing process to add another Ultrasonic Welder Configuration for use in their Patient Circuit assembly. |