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FDA 510(k)

CORVIS ST

K-Number: K113066 · 2012-11-08

ApplicantOculus Optikgerate GmbH
Decision Date2012-11-08
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CORVIS ST is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Optikgerate GmbH. It received FDA 510(k) clearance on 2012-11-08 under 510(k) number K113066. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORVIS ST?

CORVIS ST is a medical device that received FDA 510(k) clearance on 2012-11-08. The listed applicant is Oculus Optikgerate GmbH. The 510(k) number is K113066.

When did CORVIS ST receive FDA 510(k) clearance?

CORVIS ST received FDA 510(k) clearance on 2012-11-08, under 510(k) number K113066.

Who is the listed applicant for CORVIS ST?

The FDA 510(k) record lists Oculus Optikgerate GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORVIS ST?

The FDA product code for CORVIS ST is HKX.

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Other records listing Oculus Optikgerate GmbH as applicant

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Related Devices (Code: HKX)

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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