FDA Product Code
FDA Product Code NKA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2990
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190575 | iBreastExam | Ue Lifesciences, Inc. | 2019-07-16 | Abbreviated | PDF ↗ |
| K181672 | SureTouch Mobile Pressure Mapping System | Sure, Inc. | 2019-06-28 | Traditional | PDF ↗ |
| K142926 | iBreastExam | Ue Lifesciences, Inc. | 2015-04-23 | Abbreviated | PDF ↗ |
| DEN020001 | BREASTVIEW VISUAL MAPPING SYSTEM | Assurance Medical | 2003-01-31 | Post-NSE | — |
Product code NKA · Class II · Obstetrics/Gynecology. Data: openFDA.