FDA Product Code
FDA Product Code KXZ — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2982
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K851034 | NOVATHERM | Medtech Products, Inc. | 1985-09-27 | Traditional | PDF ↗ |
| K843124 | Q-SCAN THERMOGRAPHY SYSTEM | Qmax Medical, Inc. | 1984-11-29 | Traditional | PDF ↗ |
| K832731 | BREAST & BODY HEALTH SYSTEM 2000 | American Thermal Instruments, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K813547 | THERMASCAN | Bcd Products, Inc. | 1982-03-12 | Traditional | PDF ↗ |
| K781916 | FLEXT-THERM | E-Z-Em, Inc. | 1979-02-02 | Traditional | PDF ↗ |
| K770986 | FLEXI-THERM FILM | E-Z-Em, Inc. | 1977-09-12 | Traditional | PDF ↗ |
| K770678 | ELC-THERMO-SYSTEM | Cutter Laboratories, Inc. | 1977-05-25 | Traditional | PDF ↗ |
Product code KXZ · Class III · Obstetrics/Gynecology. Data: openFDA.