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FDA 510(k)

ARDO Bellis

K-Number: K230590 · 2023-03-30

ApplicantArdo Medical AG
Decision Date2023-03-30
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ARDO Bellis is a medical device manufactured by Ardo Medical AG. It received FDA 510(k) clearance on 2023-03-30 under approval number K230590. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARDO Bellis?

ARDO Bellis is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Ardo Medical AG. The 510(k) number is K230590.

When was ARDO Bellis approved by the FDA?

ARDO Bellis received FDA 510(k) clearance on 2023-03-30, under approval number K230590.

What company makes ARDO Bellis?

ARDO Bellis is manufactured by Ardo Medical AG.

What is the FDA product code for ARDO Bellis?

The FDA product code for ARDO Bellis is HGX.

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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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