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FDA 510(k)

CLL- V1 LIGHT SOURCE

K-Number: K130819 · 2013-06-19

ApplicantOlympus Winter & Ibe GmbH
Decision Date2013-06-19
Product CodeNTN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLL- V1 LIGHT SOURCE 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 2013-06-19 under 510(k) number K130819. The device is classified under product code NTN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLL- V1 LIGHT SOURCE?

CLL- V1 LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 2013-06-19. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K130819.

When did CLL- V1 LIGHT SOURCE receive FDA 510(k) clearance?

CLL- V1 LIGHT SOURCE received FDA 510(k) clearance on 2013-06-19, under 510(k) number K130819.

Who is the listed applicant for CLL- V1 LIGHT SOURCE?

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 CLL- V1 LIGHT SOURCE?

The FDA product code for CLL- V1 LIGHT SOURCE is NTN.

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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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