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FDA 510(k)

VISITEC MAGNIFYING SPECTACLES

K-Number: K844038 · 1984-11-29

ApplicantVisitec Co.
Decision Date1984-11-29
Product CodeHOI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISITEC MAGNIFYING SPECTACLES is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1984-11-29 under 510(k) number K844038. 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 VISITEC MAGNIFYING SPECTACLES?

VISITEC MAGNIFYING SPECTACLES is a medical device that received FDA 510(k) clearance on 1984-11-29. The listed applicant is Visitec Co.. The 510(k) number is K844038.

When did VISITEC MAGNIFYING SPECTACLES receive FDA 510(k) clearance?

VISITEC MAGNIFYING SPECTACLES received FDA 510(k) clearance on 1984-11-29, under 510(k) number K844038.

Who is the listed applicant for VISITEC MAGNIFYING SPECTACLES?

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

What is the FDA product code for VISITEC MAGNIFYING SPECTACLES?

The FDA product code for VISITEC MAGNIFYING SPECTACLES is HOI.

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Other records listing Visitec Co. as applicant

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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTS

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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.K854854SYSTEMS OF SIGHT LOW VISION EYEWAREInt'L Eye Care, Inc.K844716MAGNIFYING SPECTACLES W/PLASTIC LENSESGazelle 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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