Product code LHM— Obstetrics/Gynecology

BREAST-SCAN(TM)

Classification name: System, Thermographic, Liquid Crystal
Device class: Class 1
Regulation: 21 CFR 884.2982
Advisory panel: Obstetrics/Gynecology
Total cleared: 1
First cleared: 1987-10-20
Most recent: 1987-10-20

Market context for product code LHM

FDA has cleared 1 device under product code LHM, all in 1987, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code LHM

Thermascan, Inc.1 clearance

Recent clearances under product code LHM

K872962 — BREAST-SCAN(TM)Thermascan, Inc.·1987-10-20

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