CAR · Monitor, Spinal-Fluid Pressure, Electrically Powered
General Hospital · 21 CFR 880.2460 · Class 2
Overview
| Product Code | CAR |
|---|---|
| Device Name | Monitor, Spinal-Fluid Pressure, Electrically Powered |
| Regulation | 21 CFR 880.2460 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
An electrically powered spinal fluid pressure monitor is an electrically powered device used to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal. The device includes signal amplification, conditioning, and display equipment.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920740 | EPISENSOR PLUS | Industrias Palex C/O Dma Med-Chem Corp. | Mar 7, 1994 | SESE |
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM | Bion Ent., Ltd. | Jun 15, 1993 | SESE |
| K915577 | IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE | Impra, Inc. | Mar 11, 1992 | SESE |
Top Applicants
- Bion Ent., Ltd. — 1 clearance
- Impra, Inc. — 1 clearance
- Industrias Palex C/O Dma Med-Chem Corp. — 1 clearance
