FDA 510(k)

cNeuro cDAT

K-Number: K233908 · 2024-07-01

Decision Date2024-07-01

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

cNeuro cDAT is the device name listed in this FDA 510(k) record. The listed applicant is Combinostics OY. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K233908. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cNeuro cDAT?

cNeuro cDAT is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Combinostics OY. The 510(k) number is K233908.

When did cNeuro cDAT receive FDA 510(k) clearance?

cNeuro cDAT received FDA 510(k) clearance on 2024-07-01, under 510(k) number K233908.

Who is the listed applicant for cNeuro cDAT?

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

What is the FDA product code for cNeuro cDAT?

The FDA product code for cNeuro cDAT is LLZ.

Other records listing Combinostics OY 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.