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FDA 510(k)

OPTRONICS CONTRAST ACUITY TESTER

K-Number: K854983 · 1986-02-04

ApplicantOptronics, Inc.
Decision Date1986-02-04
Product CodeHOX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTRONICS CONTRAST ACUITY TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Optronics, Inc.. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K854983. 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 OPTRONICS CONTRAST ACUITY TESTER?

OPTRONICS CONTRAST ACUITY TESTER is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is Optronics, Inc.. The 510(k) number is K854983.

When did OPTRONICS CONTRAST ACUITY TESTER receive FDA 510(k) clearance?

OPTRONICS CONTRAST ACUITY TESTER received FDA 510(k) clearance on 1986-02-04, under 510(k) number K854983.

Who is the listed applicant for OPTRONICS CONTRAST ACUITY TESTER?

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

What is the FDA product code for OPTRONICS CONTRAST ACUITY TESTER?

The FDA product code for OPTRONICS CONTRAST ACUITY TESTER 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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