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FDA 510(k)

CORNEAL TOPOGRAPHY SYSTEM

K-Number: K923435 · 1993-02-16

ApplicantPar Microsystems Corp.
Decision Date1993-02-16
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CORNEAL TOPOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Par Microsystems Corp.. It received FDA 510(k) clearance on 1993-02-16 under 510(k) number K923435. 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 CORNEAL TOPOGRAPHY SYSTEM?

CORNEAL TOPOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-02-16. The listed applicant is Par Microsystems Corp.. The 510(k) number is K923435.

When did CORNEAL TOPOGRAPHY SYSTEM receive FDA 510(k) clearance?

CORNEAL TOPOGRAPHY SYSTEM received FDA 510(k) clearance on 1993-02-16, under 510(k) number K923435.

Who is the listed applicant for CORNEAL TOPOGRAPHY SYSTEM?

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

What is the FDA product code for CORNEAL TOPOGRAPHY SYSTEM?

The FDA product code for CORNEAL TOPOGRAPHY SYSTEM 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 Par Microsystems 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.

K870039IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM

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

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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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