Central Vision Analyzer Model 1000

FDA 510(k) K100095 · Vimetrics,Llc.

Substantially Equivalent

510(k) numberK100095

Submission

Device name
Central Vision Analyzer Model 1000
Applicant
Vimetrics,Llc.
Media, PA, US
Received
January 13, 2010
Decision date
May 10, 2010
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HOX – Chart, Visual Acuity
Device class
Class I (low risk)
Regulation
21 CFR 886.1150
Specialty
Ophthalmic

Other 510(k)s with product code HOX

510(k)DeviceApplicantDecision
K944156Heine Lambda 100HOX · Traditional Heine USA , Ltd.01/12/1995SE
K881971Occu-Tech Vision TestHOX · Traditional Applied Vision Concepts, Inc.11/25/1988SE
K883337PL 20/20 Infant Vision TesterHOX · Traditional Optimed Technologies, Inc.10/31/1988SE
K882634Visual Contrast Sensiti., Potential Acuity&GlareHOX · Traditional Vistech Consultants, Inc.07/15/1988SE
K881358PG Consen Contrast Sensitivity Testing ProgramHOX · Traditional Neuroscientific Corp.06/27/1988SE
K881059MCT 8000 (Multi-Vision Contrast Tester)HOX · Traditional Vistech Consultants, Inc.04/04/1988SE
K881023VCTS 6500 SystemHOX · Traditional Vistech Consultants, Inc.04/01/1988SE
K881022VCTS Marketing Program SystemHOX · Traditional Vistech Consultants, Inc.04/01/1988SE
K881021VCTS 700S SystemHOX · Traditional Vistech Consultants, Inc.04/01/1988SE
K880647Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional Fred Sammons, Inc.04/01/1988SE

Questions and answers

When was Central Vision Analyzer Model 1000 cleared by the FDA?

Central Vision Analyzer Model 1000 (K100095) received a 510(k) decision of Substantially Equivalent on May 10, 2010, 117 days after the submission was received.

What is the product code of K100095?

The FDA product code is HOX – Chart, Visual Acuity, a Class I (low risk) device regulated under 21 CFR 886.1150.