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FDA 510(k)

EYETECH-VISION SCREENING SYSTEM

K-Number: K803256 · 1981-03-04

ApplicantEyedex
Decision Date1981-03-04
Product CodeHOX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYETECH-VISION SCREENING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eyedex. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K803256. The device is classified under product code HOX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYETECH-VISION SCREENING SYSTEM?

EYETECH-VISION SCREENING SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Eyedex. The 510(k) number is K803256.

When did EYETECH-VISION SCREENING SYSTEM receive FDA 510(k) clearance?

EYETECH-VISION SCREENING SYSTEM received FDA 510(k) clearance on 1981-03-04, under 510(k) number K803256.

Who is the listed applicant for EYETECH-VISION SCREENING SYSTEM?

The FDA 510(k) record lists Eyedex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYETECH-VISION SCREENING SYSTEM?

The FDA product code for EYETECH-VISION SCREENING SYSTEM is HOX.

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Related Devices (Code: HOX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100095CENTRAL VISION ANALYZER MODEL 1000Vimetrics,Llc.K944156HEINE LAMBDA 100Heine USA , Ltd.K881971OCCU-TECH VISION TESTApplied Vision Concepts, Inc.K883337PL 20/20 INFANT VISION TESTEROptimed Technologies, Inc.K882634VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLAREVistech Consultants, Inc.K881358PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAMNeuroscientific Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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