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FDA 510(k)

PL 20/20 INFANT VISION TESTER

K-Number: K883337 · 1988-10-31

ApplicantOptimed Technologies, Inc.
Decision Date1988-10-31
Product CodeHOX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PL 20/20 INFANT VISION TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Optimed Technologies, Inc.. It received FDA 510(k) clearance on 1988-10-31 under 510(k) number K883337. 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 PL 20/20 INFANT VISION TESTER?

PL 20/20 INFANT VISION TESTER is a medical device that received FDA 510(k) clearance on 1988-10-31. The listed applicant is Optimed Technologies, Inc.. The 510(k) number is K883337.

When did PL 20/20 INFANT VISION TESTER receive FDA 510(k) clearance?

PL 20/20 INFANT VISION TESTER received FDA 510(k) clearance on 1988-10-31, under 510(k) number K883337.

Who is the listed applicant for PL 20/20 INFANT VISION TESTER?

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

What is the FDA product code for PL 20/20 INFANT VISION TESTER?

The FDA product code for PL 20/20 INFANT VISION TESTER is HOX.

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Other records listing Optimed Technologies, Inc. as applicant

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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.K882634VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLAREVistech Consultants, Inc.K881358PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAMNeuroscientific Corp.K881059MCT 8000 (MULTI-VISION CONTRAST TESTER)Vistech Consultants, Inc.

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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