NHM — Sheet, Recording, Breast Examination Class II
FDA product code NHM covers "Sheet, Recording, Breast Examination", a Class II medical device regulated under 21 CFR 884.2990. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NHM
- Device Class
- Class II
- Regulation Number
- 884.2990
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.