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FDA 510(k)

TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER

K-Number: K945382 · 1995-01-31

ApplicantExpertech Assoc., Inc.
Decision Date1995-01-31
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Expertech Assoc., Inc.. It received FDA 510(k) clearance on 1995-01-31 under 510(k) number K945382. 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 TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER?

TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER is a medical device that received FDA 510(k) clearance on 1995-01-31. The listed applicant is Expertech Assoc., Inc.. The 510(k) number is K945382.

When did TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER receive FDA 510(k) clearance?

TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER received FDA 510(k) clearance on 1995-01-31, under 510(k) number K945382.

Who is the listed applicant for TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER?

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

What is the FDA product code for TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER?

The FDA product code for TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER is HLQ.

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Other records listing Expertech Assoc., 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.

K962532RODENSTOCK SLITLAMP (MODEL 5000 & 4000)

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.K944207TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.K944616KERATRON CORNEAL TOPOGRAPHERAlliance Medical MarketinigK940647ORBSCAN(TM) KERATOMETEROrbtek, Inc.

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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