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FDA 510(k)

SYSTEMS OF SIGHT LOW VISION EYEWARE

K-Number: K854854 · 1986-02-04

ApplicantInt'L Eye Care, Inc.
Decision Date1986-02-04
Product CodeHOI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SYSTEMS OF SIGHT LOW VISION EYEWARE is the device name listed in this FDA 510(k) record. The listed applicant is Int'L Eye Care, Inc.. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K854854. The device is classified under product code HOI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMS OF SIGHT LOW VISION EYEWARE?

SYSTEMS OF SIGHT LOW VISION EYEWARE is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is Int'L Eye Care, Inc.. The 510(k) number is K854854.

When did SYSTEMS OF SIGHT LOW VISION EYEWARE receive FDA 510(k) clearance?

SYSTEMS OF SIGHT LOW VISION EYEWARE received FDA 510(k) clearance on 1986-02-04, under 510(k) number K854854.

Who is the listed applicant for SYSTEMS OF SIGHT LOW VISION EYEWARE?

The FDA 510(k) record lists Int'L Eye Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEMS OF SIGHT LOW VISION EYEWARE?

The FDA product code for SYSTEMS OF SIGHT LOW VISION EYEWARE is HOI.

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Related Devices (Code: HOI)

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.

K943613NILSing Wah International Enterprises , Ltd.K930435SPECTACLE FRAMESVenis DI A. VendrameK931328PYRAMID SUNGLASSES/PYRAMID READING GLASSESPyramidK910329SUNGLASSESCutler & Gross Sloan Optical , Ltd.K844716MAGNIFYING SPECTACLES W/PLASTIC LENSESGazelle Corp.K844038VISITEC MAGNIFYING SPECTACLESVisitec Co.

Official Source

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

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