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510(k) K100095

Device
CENTRAL VISION ANALYZER MODEL 1000
Applicant
VIMETRICS,LLC.
510(k) number
K100095
Product code
HOX  
Decision
Substantially Equivalent (SESE)
Decision date
2010-05-10
Date received
2010-01-13
Regulation
886.1150
Classification name
Chart, Visual Acuity
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN H H SINCLAIR,MD
Address
311 E. Baltimore Ave. Suite 100 Media PA US 19063 19063

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HOX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944156HEINE LAMBDA 100Heine USA , Ltd.1995-01-12
K881971OCCU-TECH VISION TESTApplied Vision Concepts, Inc.1988-11-25
K883337PL 20/20 INFANT VISION TESTEROptimed Technologies, Inc.1988-10-31
K882634VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLAREVistech Consultants, Inc.1988-07-15
K881358PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAMNeuroscientific Corp.1988-06-27
K881059MCT 8000 (MULTI-VISION CONTRAST TESTER)Vistech Consultants, Inc.1988-04-04
K881023VCTS 6500 SYSTEMVistech Consultants, Inc.1988-04-01
K881022VCTS MARKETING PROGRAM SYSTEMVistech Consultants, Inc.1988-04-01
K881021VCTS 700S SYSTEMVistech Consultants, Inc.1988-04-01
K880647ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)Fred Sammons, Inc.1988-04-01
K875237OPTEC 1000 DMV VISION TESTER MODIFYStereo Optical Co., Inc.1988-03-17
K875112MENTOR B-VAT(TM) II VIDEO TESTERMentor O & O, Inc.1988-03-08
K873916'E' CUBE AND 'E' PADRichmond Products, Inc.1987-12-11
K873909READING CHARTS-CARDS (DISTANCE AND NEARPOINT)Richmond Products, Inc.1987-10-28
K863509OPTEC 1000 DMVStereo Optical Co., Inc.1986-11-10

Legacy Summary#

summary

FDA Review#

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