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FDA 510(k)

OPTIVU HDVD SYSTEM

K-Number: K001169 · 2000-05-16

ApplicantOptimize, Inc.
Decision Date2000-05-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTIVU HDVD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Optimize, Inc.. It received FDA 510(k) clearance on 2000-05-16 under 510(k) number K001169. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIVU HDVD SYSTEM?

OPTIVU HDVD SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-16. The listed applicant is Optimize, Inc.. The 510(k) number is K001169.

When did OPTIVU HDVD SYSTEM receive FDA 510(k) clearance?

OPTIVU HDVD SYSTEM received FDA 510(k) clearance on 2000-05-16, under 510(k) number K001169.

Who is the listed applicant for OPTIVU HDVD SYSTEM?

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

What is the FDA product code for OPTIVU HDVD SYSTEM?

The FDA product code for OPTIVU HDVD SYSTEM is GCJ.

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Related Devices (Code: GCJ)

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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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