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FDA 510(k)

AUTOKERATOMETER, INSTRUMENT

K-Number: K781994 · 1979-02-12

ApplicantZeiss Humphrey System
Decision Date1979-02-12
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOKERATOMETER, INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Zeiss Humphrey System. It received FDA 510(k) clearance on 1979-02-12 under 510(k) number K781994. The device is classified under product code HLQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOKERATOMETER, INSTRUMENT?

AUTOKERATOMETER, INSTRUMENT is a medical device that received FDA 510(k) clearance on 1979-02-12. The listed applicant is Zeiss Humphrey System. The 510(k) number is K781994.

When did AUTOKERATOMETER, INSTRUMENT receive FDA 510(k) clearance?

AUTOKERATOMETER, INSTRUMENT received FDA 510(k) clearance on 1979-02-12, under 510(k) number K781994.

Who is the listed applicant for AUTOKERATOMETER, INSTRUMENT?

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

What is the FDA product code for AUTOKERATOMETER, INSTRUMENT?

The FDA product code for AUTOKERATOMETER, INSTRUMENT is HLQ.

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Other records listing Zeiss Humphrey System 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.

K942439ZEISS OPMILAS 144 SURGICAL LASERSK923211DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPEK923348OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIEDK852639HUMPHREY FIELD ANALYZER MODEL 630K852638HUMPHREY IMAGE ANALYZER MODEL 110K821940THE HUMPHREY FIELD ANALYZER MODEL 610

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Related Devices (Code: HLQ)

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.

K003299OPD-SCAN, MODELS ARK-10000 AND ARK-9000Nidek Co., Ltd.K973756EYE SYS VISTAEyesys Technologies, Inc.K964290EYECHEKReichert Ophthalmic Instruments, Div. Leica, Inc.K945382TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.K944207TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.K944616KERATRON CORNEAL TOPOGRAPHERAlliance Medical Marketinig

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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