FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ventilator, High Frequency
PMA: P890057
·
Supplement: S003
·
Decision Sep 15, 1995
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Ventilator, High Frequency
- Trade Name
- MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.
- PMA Number
- P890057
- Supplement Number
- S003
- 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
- September 15, 1995
- Date Received
- June 29, 1992
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
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 |