Product code NHM

Device name

Sheet, Recording, Breast Examination

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

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

Source

FDA openFDA device classification dataset