FDA 510(k)

cNeuro cPET

K-Number: K231576 · 2023-09-14

Decision Date2023-09-14

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

cNeuro cPET is the device name listed in this FDA 510(k) record. The listed applicant is Combinostics OY. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K231576. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cNeuro cPET?

cNeuro cPET is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Combinostics OY. The 510(k) number is K231576.

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

cNeuro cPET received FDA 510(k) clearance on 2023-09-14, under 510(k) number K231576.

Who is the listed applicant for cNeuro cPET?

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 cPET?

The FDA product code for cNeuro cPET is KPS.

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.

K233908cNeuro cDAT K171328cNeuro cMRI

Related Devices (Code: KPS)

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.