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FDA 510(k)

NAVOYCDS

K-Number: K240558 · 2024-07-22

ApplicantAlgodx AB
Decision Date2024-07-22
Product CodePLB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAVOYCDS is the device name listed in this FDA 510(k) record. The listed applicant is Algodx AB. It received FDA 510(k) clearance on 2024-07-22 under 510(k) number K240558. The device is classified under product code PLB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVOYCDS?

NAVOYCDS is a medical device that received FDA 510(k) clearance on 2024-07-22. The listed applicant is Algodx AB. The 510(k) number is K240558.

When did NAVOYCDS receive FDA 510(k) clearance?

NAVOYCDS received FDA 510(k) clearance on 2024-07-22, under 510(k) number K240558.

Who is the listed applicant for NAVOYCDS?

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

What is the FDA product code for NAVOYCDS?

The FDA product code for NAVOYCDS is PLB.

Related Devices (Code: PLB)

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

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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