DeviceClearance

Product code HCS— Neurology

EXOPHTHALMOMETER

Classification name
Device, Temperature Measurement, Direct Contact, Powered
Device class
Class 2
Regulation
21 CFR 882.1570
Advisory panel
Neurology
Total cleared
8
First cleared
Most recent

Market context for product code HCS

FDA has cleared 8 devices under product code HCS between 1982 and 1998, filed by 7 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.

Clearances per year

Top applicants under product code HCS

Recent clearances under product code HCS

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