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FDA 510(k)

MODEL 2000 INTRAOPERATIVE CORNEASCOPE

K-Number: K901009 · 1990-05-30

ApplicantKera Corp.
Decision Date1990-05-30
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 2000 INTRAOPERATIVE CORNEASCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Kera Corp.. It received FDA 510(k) clearance on 1990-05-30 under 510(k) number K901009. 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 MODEL 2000 INTRAOPERATIVE CORNEASCOPE?

MODEL 2000 INTRAOPERATIVE CORNEASCOPE is a medical device that received FDA 510(k) clearance on 1990-05-30. The listed applicant is Kera Corp.. The 510(k) number is K901009.

When did MODEL 2000 INTRAOPERATIVE CORNEASCOPE receive FDA 510(k) clearance?

MODEL 2000 INTRAOPERATIVE CORNEASCOPE received FDA 510(k) clearance on 1990-05-30, under 510(k) number K901009.

Who is the listed applicant for MODEL 2000 INTRAOPERATIVE CORNEASCOPE?

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

What is the FDA product code for MODEL 2000 INTRAOPERATIVE CORNEASCOPE?

The FDA product code for MODEL 2000 INTRAOPERATIVE CORNEASCOPE is HLQ.

Related Clinical Trials

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.

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Other records listing Kera Corp. 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.

K871479VIDEOSCAN (TM)K864037KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZERK850665CORNEASCOPE MODEL 1200

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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