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FDA 510(k)

OEC Elite

K-Number: K172550 · 2017-11-16

ApplicantGe Oec Medical Systems, Inc.
Decision Date2017-11-16
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC Elite is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K172550. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OEC Elite?

OEC Elite is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Ge Oec Medical Systems, Inc.. The 510(k) number is K172550.

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

OEC Elite received FDA 510(k) clearance on 2017-11-16, under 510(k) number K172550.

Who is the listed applicant for OEC Elite?

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

What is the FDA product code for OEC Elite?

The FDA product code for OEC Elite is OXO.

Other records listing Ge Oec Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233669OEC 3DK203346OEC 3DK192819OEC EliteK171565OEC Elite

Related Devices (Code: OXO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.

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.

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