FDA 510(k)

OTI-SCAN 3000

K-Number: K092837 · 2009-12-23

Decision Date2009-12-23

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OTI-SCAN 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Opko Instrumentation, Inc.. It received FDA 510(k) clearance on 2009-12-23 under 510(k) number K092837. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTI-SCAN 3000?

OTI-SCAN 3000 is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Opko Instrumentation, Inc.. The 510(k) number is K092837.

When did OTI-SCAN 3000 receive FDA 510(k) clearance?

OTI-SCAN 3000 received FDA 510(k) clearance on 2009-12-23, under 510(k) number K092837.

Who is the listed applicant for OTI-SCAN 3000?

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

What is the FDA product code for OTI-SCAN 3000?

The FDA product code for OTI-SCAN 3000 is IYO.

Related Devices (Code: IYO)

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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.