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
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K981805 | pos technologies | POS T-7000 | August 7, 1998 |
| K974208 | titronics research and development | TYTRON C-3000 | February 3, 1998 |
| K950986 | artronics | NEUROREADER | November 9, 1995 |
| K894772 | medtech instruments | THERMALGRAPHIC ANALYSER | October 3, 1989 |
| K840487 | k.j. electronics | T-METER | March 12, 1984 |
| K831995 | gabriel ent | TRENDO-SCOPE | August 8, 1983 |
| K822795 | gabriel ent | GABRIEL DIGITREND | October 8, 1982 |
| K821107 | medical equipment designs | EXOPHTHALMOMETER | June 14, 1982 |