FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Ventilator, High Frequency
PMA: P850064
·
Supplement: S046
·
Decision Jun 25, 2021
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
- S046
- Device Class
- FDA Class 3
- Product Code
- LSZ
- Generic Name
- VENTILATOR, HIGH FREQUENCY
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- June 25, 2021
- Date Received
- May 27, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
New process using the 844USB EPRO programmer.
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 |