Monitor, Spinal-Fluid Pressure, Electrically Powered
The Electrically Powered Spinal-Fluid Pressure Monitor is a general hospital device used to measure and display intracranial or spinal fluid pressure in patients requiring continuous intracranial pressure monitoring, commonly in neurocritical care settings. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAR, regulated under 21 CFR 880.2460, within the General Hospital medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CAR
- Device Class
- FDA class 2
- Regulation Number
- 880.2460
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920740 | EPISENSOR PLUS | Mar 07, 1994 | Substantially Equivalent | Industrias Palex C/O Dma Med-Chem Corp. |
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM | Jun 15, 1993 | Substantially Equivalent | Bion Ent., Ltd. |
| K915577 | IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE | Mar 11, 1992 | Substantially Equivalent | Impra, Inc. |