DeviceClearance

Product code NHM— Obstetrics/Gynecology

SAFETOUCH

Classification name
Sheet, Recording, Breast Examination
Device class
Class 2
Regulation
21 CFR 884.2990
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NHM under 21 CFR 884.2990, via openFDA

Market context for product code NHM

FDA has cleared 2 devices under product code NHM, all in 2002, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NHM

Recent clearances under product code NHM

Data sourced from openFDA. This site is unofficial and independent of the FDA.