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FDA 510(k)

WOODLYN CLASSIC CATARACT ACUITY TEST

K-Number: K843812 · 1984-12-11

ApplicantWoodlyn, Inc.
Decision Date1984-12-11
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

WOODLYN CLASSIC CATARACT ACUITY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Woodlyn, Inc.. It received FDA 510(k) clearance on 1984-12-11 under 510(k) number K843812. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOODLYN CLASSIC CATARACT ACUITY TEST?

WOODLYN CLASSIC CATARACT ACUITY TEST is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Woodlyn, Inc.. The 510(k) number is K843812.

When did WOODLYN CLASSIC CATARACT ACUITY TEST receive FDA 510(k) clearance?

WOODLYN CLASSIC CATARACT ACUITY TEST received FDA 510(k) clearance on 1984-12-11, under 510(k) number K843812.

Who is the listed applicant for WOODLYN CLASSIC CATARACT ACUITY TEST?

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

What is the FDA product code for WOODLYN CLASSIC CATARACT ACUITY TEST?

The FDA product code for WOODLYN CLASSIC CATARACT ACUITY TEST is HLI.

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Other records listing Woodlyn, Inc. 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.

K931303WOODLYN OPERATION MICROSCOPEK920861WOODLYN CLASSIC LENSMETERK900476WOODLYN SLIT LAMP MODEL HR-1K900477WOODLYN CLASSIC SLIT LAMP MODEL SMMK900478WOODLYN FULL APERTURE TRIAL LENS SETK890992WOODLYN OPHTHALMIC PROJECTOR

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Related Devices (Code: HLI)

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K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KGK121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems 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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