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FDA 510(k)

Anterion

K-Number: K230897 · 2023-10-11

ApplicantHeidelberg Engineering GmbH
Decision Date2023-10-11
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Anterion is a medical device manufactured by Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2023-10-11 under approval number K230897. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anterion?

Anterion is a medical device that received FDA 510(k) clearance on 2023-10-11. It is manufactured by Heidelberg Engineering GmbH. The 510(k) number is K230897.

When was Anterion approved by the FDA?

Anterion received FDA 510(k) clearance on 2023-10-11, under approval number K230897.

What company makes Anterion?

Anterion is manufactured by Heidelberg Engineering GmbH.

What is the FDA product code for Anterion?

The FDA product code for Anterion is OBO.

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Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd.

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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