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FDA 510(k)

C50

K-Number: K223470 · 2023-12-14

ApplicantSopro
Decision Date2023-12-14
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

C50 is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K223470. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C50?

C50 is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Sopro. The 510(k) number is K223470.

When did C50 receive FDA 510(k) clearance?

C50 received FDA 510(k) clearance on 2023-12-14, under 510(k) number K223470.

Who is the listed applicant for C50?

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

What is the FDA product code for C50?

The FDA product code for C50 is NBL.

Related Devices (Code: NBL)

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.

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.