LifePulse High Frequency Ventilator
FDA premarket approval P850064/S038 · decided 2018-11-19
Approval details
- PMA number
- P850064
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LifePulse High Frequency Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2018-10-25
- Decision date
- 2018-11-19
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Adding an additional supplier of the Patient Box standoffs that are used in both models of the Patient Box (312 and 314). The change proposed does not affect the performance of the Patient Box and thus the LifePulse High Frequency Ventilator is not affected. There is no change to the design or any labeling. The following manufacturing facility is affected by the change(s): Bunnell Incorporated, 436 Lawndale Drive, Salt Lake City, Utah.
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