FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ventilator, High Frequency
PMA: P850064
·
Supplement: S036
·
Decision Apr 27, 2018
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Ventilator, High Frequency
- Trade Name
- LifePulse High Frequency Ventilator
- PMA Number
- P850064
- Supplement Number
- S036
- Device Class
- FDA Class 3
- Product Code
- LSZ
- Generic Name
- VENTILATOR, HIGH FREQUENCY
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 27, 2018
- Date Received
- January 29, 2018
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for adding a Funnel shape to the machine end of the 5.5 mm LifePort Adapter via the molding process. The disposable LifePort Adapters were approved for use with the LifePulse High Frequency Ventilator Model 204 in 1995.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LSZ | Ventilator, High Frequency | FDA class 3 | Unknown |