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FDA 510(k)

OEC One ASD

K-Number: K240828 · 2024-12-27

ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2024-12-27
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC One ASD 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 2024-12-27 under 510(k) number K240828. 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 One ASD?

OEC One ASD is a medical device that received FDA 510(k) clearance on 2024-12-27. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K240828.

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

OEC One ASD received FDA 510(k) clearance on 2024-12-27, under 510(k) number K240828.

Who is the listed applicant for OEC One ASD?

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 ASD?

The FDA product code for OEC One ASD is OXO.

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

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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

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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