FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Controller, Closed-Loop, Blood-Pressure
PMA: P860035
·
Decision Dec 17, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Controller, Closed-Loop, Blood-Pressure
- Trade Name
- TITRATOR MODEL 10K
- PMA Number
- P860035
- Device Class
- FDA Class 3
- Product Code
- LSX
- Generic Name
- CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE
- Medical Specialty
- Unknown
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 17, 1987
- Date Received
- August 21, 1986
- Expedited Review
- N
- Docket Number
- 88M-0005
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 |
|---|---|---|---|
| LSX | Controller, Closed-Loop, Blood-Pressure | FDA class 3 | Unknown |