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FDA 510(k)

ESG-300, APU-300, Pressure Reducer, MAPC Probes

K-Number: K180200 · 2018-04-26

ApplicantOlympus Winter & Ibe GmbH
Decision Date2018-04-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESG-300, APU-300, Pressure Reducer, MAPC Probes 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 2018-04-26 under 510(k) number K180200. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESG-300, APU-300, Pressure Reducer, MAPC Probes?

ESG-300, APU-300, Pressure Reducer, MAPC Probes is a medical device that received FDA 510(k) clearance on 2018-04-26. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K180200.

When did ESG-300, APU-300, Pressure Reducer, MAPC Probes receive FDA 510(k) clearance?

ESG-300, APU-300, Pressure Reducer, MAPC Probes received FDA 510(k) clearance on 2018-04-26, under 510(k) number K180200.

Who is the listed applicant for ESG-300, APU-300, Pressure Reducer, MAPC Probes?

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 ESG-300, APU-300, Pressure Reducer, MAPC Probes?

The FDA product code for ESG-300, APU-300, Pressure Reducer, MAPC Probes is GEI.

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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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