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FDA 510(k)

ANT-X System

K-Number: K230185 · 2023-06-01

ApplicantNdr Medical Technology Pte. , Ltd.
Decision Date2023-06-01
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANT-X System is the device name listed in this FDA 510(k) record. The listed applicant is Ndr Medical Technology Pte. , Ltd.. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K230185. 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 ANT-X System?

ANT-X System is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Ndr Medical Technology Pte. , Ltd.. The 510(k) number is K230185.

When did ANT-X System receive FDA 510(k) clearance?

ANT-X System received FDA 510(k) clearance on 2023-06-01, under 510(k) number K230185.

Who is the listed applicant for ANT-X System?

The FDA 510(k) record lists Ndr Medical Technology Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANT-X System?

The FDA product code for ANT-X System is OWB.

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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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