Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2460](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2460) → CAR — Monitor, Spinal-Fluid Pressure, Electrically Powered

# CAR · Monitor, Spinal-Fluid Pressure, Electrically Powered

_General Hospital · 21 CFR 880.2460 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/CAR

## Overview

- **Product Code:** CAR
- **Device Name:** Monitor, Spinal-Fluid Pressure, Electrically Powered
- **Regulation:** [21 CFR 880.2460](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2460)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **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](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/CAR/K920740.md) | EPISENSOR PLUS | Industrias Palex C/O Dma Med-Chem Corp. | Mar 7, 1994 | SESE |
| [K926066](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/CAR/K926066.md) | BION MUMPS-G ANTIBODY TEST SYSTEM | Bion Ent., Ltd. | Jun 15, 1993 | SESE |
| [K915577](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/CAR/K915577.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/CAR](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/CAR)

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