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FDA 510(k)

SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE

K-Number: K981665 · 1998-12-07

ApplicantBio-Medical Sciences, Inc.
Decision Date1998-12-07
Product CodeMMQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Sciences, Inc.. It received FDA 510(k) clearance on 1998-12-07 under 510(k) number K981665. 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 SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE?

SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Bio-Medical Sciences, Inc.. The 510(k) number is K981665.

When did SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE receive FDA 510(k) clearance?

SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE received FDA 510(k) clearance on 1998-12-07, under 510(k) number K981665.

Who is the listed applicant for SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE?

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

What is the FDA product code for SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE?

The FDA product code for SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE is MMQ.

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Other records listing Bio-Medical Sciences, 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.

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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.

K964702EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800Euclid Systems Corp.K964891ORBSHOT KERATOMETEROrbtek, Inc.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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