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FDA 510(k)

ORBSHOT KERATOMETER

K-Number: K964891 · 1997-03-26

ApplicantOrbtek, Inc.
Decision Date1997-03-26
Product CodeMMQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORBSHOT 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 1997-03-26 under 510(k) number K964891. The device is classified under product code MMQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORBSHOT KERATOMETER?

ORBSHOT KERATOMETER is a medical device that received FDA 510(k) clearance on 1997-03-26. The listed applicant is Orbtek, Inc.. The 510(k) number is K964891.

When did ORBSHOT KERATOMETER receive FDA 510(k) clearance?

ORBSHOT KERATOMETER received FDA 510(k) clearance on 1997-03-26, under 510(k) number K964891.

Who is the listed applicant for ORBSHOT 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 ORBSHOT KERATOMETER?

The FDA product code for ORBSHOT KERATOMETER is MMQ.

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.

K940647ORBSCAN(TM) KERATOMETER

Related Devices (Code: MMQ)

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.

K981665SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICEBio-Medical Sciences, Inc.K964702EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800Euclid Systems Corp.K963762CORNEAL TOPOGRAPHER 200Eclipse VenturesK950077INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)Par Vision Systems Corp.

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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