Product code NKA
- Device name
- System, Documentation, Breast Lesion
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.2990
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.
- Source
- FDA openFDA device classification dataset