FDA 510(k)

ULTRA Telescopes

K-Number: K153009 · 2016-04-05

Decision Date2016-04-05

Product CodeEOB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

ULTRA Telescopes is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2016-04-05 under approval number K153009. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA Telescopes?

ULTRA Telescopes is a medical device that received FDA 510(k) clearance on 2016-04-05. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K153009.

When was ULTRA Telescopes approved by the FDA?

ULTRA Telescopes received FDA 510(k) clearance on 2016-04-05, under approval number K153009.

What company makes ULTRA Telescopes?

ULTRA Telescopes is manufactured by Olympus Winter & Ibe GmbH.

What is the FDA product code for ULTRA Telescopes?

The FDA product code for ULTRA Telescopes is EOB.

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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.