HCS — Device, Temperature Measurement, Direct Contact, Powered Class II
FDA product code HCS covers "Device, Temperature Measurement, Direct Contact, Powered", a Class II medical device regulated under 21 CFR 882.1570. Submissions are reviewed by the Neurology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HCS
- Device Class
- Class II
- Regulation Number
- 882.1570
- Submission Type
- 510(k)
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K981805 | Pos Technologies | POS T-7000 | Aug 7, 1998 |
| K974208 | Titronics Research And Development | TYTRON C-3000 | Feb 3, 1998 |
| K950986 | Artronics | NEUROREADER | Nov 9, 1995 |
| K894772 | Medtech Instruments | THERMALGRAPHIC ANALYSER | Oct 3, 1989 |
| K840487 | K.J. Electronics | T-METER | Mar 12, 1984 |
| K831995 | Gabriel Ent | TRENDO-SCOPE | Aug 8, 1983 |
| K822795 | Gabriel Ent | GABRIEL DIGITREND | Oct 8, 1982 |
| K821107 | Medical Equipment Designs | EXOPHTHALMOMETER | Jun 14, 1982 |