FDA 510(k)

OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4

K-Number: K020507 · 2002-10-08

Decision Date2002-10-08

Product CodeGWG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 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 2002-10-08 under 510(k) number K020507. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4?

OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K020507.

When did OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 receive FDA 510(k) clearance?

OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 received FDA 510(k) clearance on 2002-10-08, under 510(k) number K020507.

Who is the listed applicant for OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4?

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 OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4?

The FDA product code for OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 is GWG.

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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.