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FDA 510(k)

RTVUE CAM WITH CORNEAL POWER UPGRADE

K-Number: K111505 · 2011-09-08

ApplicantOptovue, Inc.
Decision Date2011-09-08
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RTVUE CAM WITH CORNEAL POWER UPGRADE is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2011-09-08 under 510(k) number K111505. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTVUE CAM WITH CORNEAL POWER UPGRADE?

RTVUE CAM WITH CORNEAL POWER UPGRADE is a medical device that received FDA 510(k) clearance on 2011-09-08. The listed applicant is Optovue, Inc.. The 510(k) number is K111505.

When did RTVUE CAM WITH CORNEAL POWER UPGRADE receive FDA 510(k) clearance?

RTVUE CAM WITH CORNEAL POWER UPGRADE received FDA 510(k) clearance on 2011-09-08, under 510(k) number K111505.

Who is the listed applicant for RTVUE CAM WITH CORNEAL POWER UPGRADE?

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

What is the FDA product code for RTVUE CAM WITH CORNEAL POWER UPGRADE?

The FDA product code for RTVUE CAM WITH CORNEAL POWER UPGRADE is OBO.

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Related Devices (Code: OBO)

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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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