Product code HIW— Ophthalmic

ANOMALOSCOPE QUADRANT TEST-6

Classification name: Anomaloscope
Device class: Class 1
Regulation: 21 CFR 886.1070
Advisory panel: Ophthalmic
Total cleared: 3
First cleared: 1986-04-04
Most recent: 1994-02-25

Market context for product code HIW

FDA has cleared 3 devices under product code HIW between 1986 and 1994, filed by 3 applicant companies. 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.

Clearances per year

19941 clearance
19911 clearance
19861 clearance

Top applicants under product code HIW

Lkc Technologies, Inc.1 clearance
Chromagraphics, Inc.1 clearance
Bova Intl.1 clearance

Recent clearances under product code HIW

K930575 — KAMPPETER ANOMALOSCOPEBova Intl.·1994-02-25
K913962 — ANOMALOSCOPE QUADRANT TEST-6Lkc Technologies, Inc.·1991-10-23
K860174 — GUNKEL CHROMAGRAPH COLOR VISION TESTERChromagraphics, Inc.·1986-04-04

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