HCS · Device, Temperature Measurement, Direct Contact, Powered
Neurology · 21 CFR 882.1570 · Class 2
Overview
| Product Code | HCS |
|---|---|
| Device Name | Device, Temperature Measurement, Direct Contact, Powered |
| Regulation | 21 CFR 882.1570 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | POS T-7000 | Pos Technologies, Inc. | Aug 7, 1998 | SESE |
| K974208 | TYTRON C-3000 | Titronics Research & Development Co. | Feb 3, 1998 | SESE |
| K950986 | NEUROREADER | Artronics | Nov 9, 1995 | SESE |
| K894772 | THERMALGRAPHIC ANALYSER | Medtech Instruments | Oct 3, 1989 | SESE |
| K840487 | T-METER | K.J. Electronics | Mar 12, 1984 | SESE |
| K831995 | TRENDO-SCOPE | Gabriel Ent. | Aug 8, 1983 | SESE |
| K822795 | GABRIEL DIGITREND | Gabriel Ent. | Oct 8, 1982 | SESE |
| K821107 | 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
