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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 | S041 |
Date Received | 10/24/2019 |
Decision Date | 11/22/2019 |
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 For the LifePulse High Frequency Ventilator (HFV), to notify of a change to the manufacturing process and manufacturer of the priority alarm cover. The priority alarm cover is specific to the HFV 204. |