Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1570](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1570) → HCS — Device, Temperature Measurement, Direct Contact, Powered

# HCS · Device, Temperature Measurement, Direct Contact, Powered

_Neurology · 21 CFR 882.1570 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS

## Overview

- **Product Code:** HCS
- **Device Name:** Device, Temperature Measurement, Direct Contact, Powered
- **Regulation:** [21 CFR 882.1570](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1570)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K981805](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS/K981805.md) | POS T-7000 | Pos Technologies, Inc. | Aug 7, 1998 | SESE |
| [K974208](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS/K974208.md) | TYTRON C-3000 | Titronics Research & Development Co. | Feb 3, 1998 | SESE |
| [K950986](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS/K950986.md) | NEUROREADER | Artronics | Nov 9, 1995 | SESE |
| [K894772](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS/K894772.md) | THERMALGRAPHIC ANALYSER | Medtech Instruments | Oct 3, 1989 | SESE |
| [K840487](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS/K840487.md) | T-METER | K.J. Electronics | Mar 12, 1984 | SESE |
| [K831995](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS/K831995.md) | TRENDO-SCOPE | Gabriel Ent. | Aug 8, 1983 | SESE |
| [K822795](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS/K822795.md) | GABRIEL DIGITREND | Gabriel Ent. | Oct 8, 1982 | SESE |
| [K821107](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS/K821107.md) | EXOPHTHALMOMETER | Medical Equipment Designs, Inc. | Jun 14, 1982 | SESE |

## Top Applicants

- Gabriel Ent. — 2 clearances
- Artronics — 1 clearance
- K.J. Electronics — 1 clearance
- Medical Equipment Designs, Inc. — 1 clearance
- Medtech Instruments — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCS)

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