FDA 510(k)

ULTRA Telescopes

K-Number: K160249 · 2016-04-21

Decision Date2016-04-21

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ULTRA Telescopes is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2016-04-21 under approval number K160249. The device is classified under product code HRX. It was reviewed by the OR 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 2016-04-21. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K160249.

When was ULTRA Telescopes approved by the FDA?

ULTRA Telescopes received FDA 510(k) clearance on 2016-04-21, under approval number K160249.

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 HRX.

Other Devices by Olympus Winter & Ibe GmbH

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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.