Product Code: HCS
FDA class 2
21 CFR 882.1570
Device, Temperature Measurement, Direct Contact, Powered
Neurology
The Powered Direct Contact Temperature Measurement Device is a diagnostic instrument that measures body temperature through direct physical contact with tissue, providing real-time temperature data during surgical procedures or clinical assessment. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HCS under regulation 21 CFR 882.1570 in the Neurology specialty. It is eligible for third-party 510(k) review.
510(k)s
8
FEI Numbers
0
Registration Numbers
0
Unique Applicants
7
Years Active
16
Research product code HCS in seconds
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Basic Information
- Product Code
- HCS
- Device Class
- FDA class 2
- Regulation Number
- 882.1570
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K981805 | POS T-7000 | Aug 07, 1998 | Substantially Equivalent | Pos Technologies, Inc. |
| K974208 | TYTRON C-3000 | Feb 03, 1998 | Substantially Equivalent | Titronics Research & Development Co. |
| K950986 | NEUROREADER | Nov 09, 1995 | Substantially Equivalent | Artronics |
| K894772 | THERMALGRAPHIC ANALYSER | Oct 03, 1989 | Substantially Equivalent | Medtech Instruments |
| K840487 | T-METER | Mar 12, 1984 | Substantially Equivalent | K.J. Electronics |
| K831995 | TRENDO-SCOPE | Aug 08, 1983 | Substantially Equivalent | Gabriel Ent. |
| K822795 | GABRIEL DIGITREND | Oct 08, 1982 | Substantially Equivalent | Gabriel Ent. |
| K821107 | EXOPHTHALMOMETER | Jun 14, 1982 | Substantially Equivalent | Medical Equipment Designs, Inc. |