Sheet, Recording, Breast Examination
The Sheet, Recording, Breast Examination (product code NHM) is an obstetrics/gynecology device intended for clinicians to document the location of a palpable breast finding during physical examination, serving as a recording aide for breast examination findings, as described in its definition. It is classified as an FDA Class 2 device within the Obstetrics/Gynecology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- NHM
- Device Class
- FDA class 2
- Regulation Number
- 884.2990
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.