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FDA 510(k)

ARDO Alyssa

K-Number: K212773 · 2022-04-15

ApplicantArdo Medical AG
Decision Date2022-04-15
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ARDO Alyssa is the device name listed in this FDA 510(k) record. The listed applicant is Ardo Medical AG. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K212773. 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 Alyssa?

ARDO Alyssa is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Ardo Medical AG. The 510(k) number is K212773.

When did ARDO Alyssa receive FDA 510(k) clearance?

ARDO Alyssa received FDA 510(k) clearance on 2022-04-15, under 510(k) number K212773.

Who is the listed applicant for ARDO Alyssa?

The FDA 510(k) record lists Ardo Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARDO Alyssa?

The FDA product code for ARDO Alyssa is HGX.

Other records listing Ardo Medical AG 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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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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