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FDA 510(k)

cNeuro cPET

K-Number: K231576 · 2023-09-14

ApplicantCombinostics OY
Decision Date2023-09-14
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

cNeuro cPET is a medical device manufactured by Combinostics OY. It received FDA 510(k) clearance on 2023-09-14 under approval 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. It is manufactured by Combinostics OY. The 510(k) number is K231576.

When was cNeuro cPET approved by the FDA?

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

What company makes cNeuro cPET?

cNeuro cPET is manufactured by Combinostics OY.

What is the FDA product code for cNeuro cPET?

The FDA product code for cNeuro cPET is KPS.

Other Devices by Combinostics OY

K171328cNeuro cMRI K233908cNeuro cDAT

Related Devices (Code: KPS)

K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc. K161674QuantumCamDdd-Diagnostic A/S K162337Symbia 6.5Siemens Medical Solutions USA, Inc. K161574Discovery MIGe Medical Systems, LLC K161631MAMMIGeneral Equipment For Medical Imaging

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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