FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Ventilator, High Frequency
PMA: P890034
·
Decision Dec 13, 1991
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Ventilator, High Frequency
- Trade Name
- MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
- PMA Number
- P890034
- Device Class
- FDA Class 3
- Product Code
- LSZ
- Generic Name
- VENTILATOR, HIGH FREQUENCY
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- December 13, 1991
- Date Received
- June 5, 1989
- Expedited Review
- Y
- Docket Number
- 91M-0508
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 |