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FDA 510(k)

ULTRA Telescopes

K-Number: K160249 · 2016-04-21

ApplicantOlympus Winter & Ibe GmbH
Decision Date2016-04-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTRA Telescopes is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2016-04-21 under 510(k) 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. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K160249.

When did ULTRA Telescopes receive FDA 510(k) clearance?

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

Who is the listed applicant for ULTRA Telescopes?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA Telescopes?

The FDA product code for ULTRA Telescopes is HRX.

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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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