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FDA 510(k)

ORBSCAN(TM) KERATOMETER

K-Number: K940647 · 1994-07-06

ApplicantOrbtek, Inc.
Decision Date1994-07-06
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORBSCAN(TM) KERATOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Orbtek, Inc.. It received FDA 510(k) clearance on 1994-07-06 under 510(k) number K940647. 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 ORBSCAN(TM) KERATOMETER?

ORBSCAN(TM) KERATOMETER is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Orbtek, Inc.. The 510(k) number is K940647.

When did ORBSCAN(TM) KERATOMETER receive FDA 510(k) clearance?

ORBSCAN(TM) KERATOMETER received FDA 510(k) clearance on 1994-07-06, under 510(k) number K940647.

Who is the listed applicant for ORBSCAN(TM) KERATOMETER?

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

What is the FDA product code for ORBSCAN(TM) KERATOMETER?

The FDA product code for ORBSCAN(TM) KERATOMETER 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 Orbtek, 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.

K964891ORBSHOT KERATOMETER

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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