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FDA 510(k)

OEC One

K-Number: K172700 · 2017-11-09

ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2017-11-09
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC One is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K172700. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OEC One?

OEC One is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K172700.

When did OEC One receive FDA 510(k) clearance?

OEC One received FDA 510(k) clearance on 2017-11-09, under 510(k) number K172700.

Who is the listed applicant for OEC One?

The FDA 510(k) record lists Ge Hualun Medical Systems Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OEC One?

The FDA product code for OEC One is OWB.

Other records listing Ge Hualun Medical Systems Co. , Ltd. as applicant

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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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