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 a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2018-04-26 under approval 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. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K180200.
When was ESG-300, APU-300, Pressure Reducer, MAPC Probes approved by the FDA?
ESG-300, APU-300, Pressure Reducer, MAPC Probes received FDA 510(k) clearance on 2018-04-26, under approval number K180200.
What company makes ESG-300, APU-300, Pressure Reducer, MAPC Probes?
ESG-300, APU-300, Pressure Reducer, MAPC Probes is manufactured by Olympus Winter & Ibe GmbH.
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.