KXZ — System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) Class III
FDA product code KXZ covers "System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)", a Class III medical device regulated under 21 CFR 884.2982. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KXZ
- Device Class
- Class III
- Regulation Number
- 884.2982
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K851034 | medtech products | NOVATHERM | September 27, 1985 |
| K843124 | qmax medical | Q-SCAN THERMOGRAPHY SYSTEM | November 29, 1984 |
| K832731 | american thermal instruments | BREAST & BODY HEALTH SYSTEM 2000 | January 30, 1984 |
| K813547 | bcd products | THERMASCAN | March 12, 1982 |
| K781916 | e-z-em | FLEXT-THERM | February 2, 1979 |
| K770986 | e-z-em | FLEXI-THERM FILM | September 12, 1977 |
| K770678 | cutter laboratories | ELC-THERMO-SYSTEM | May 25, 1977 |