NHM

Sheet, Recording, Breast Examination

Product code

NHM

Device name

Sheet, Recording, Breast Examination

Device class

Class 2

21 CFR

21 CFR 884.2990

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.

Definition text from the FDA device classification database (U.S. federal government work, public domain).