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FDA 510(k)

ClearumTM HS

K-Number: K231406 · 2023-06-14

ApplicantBellco Srl
Decision Date2023-06-14
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearumTM HS is a medical device manufactured by Bellco Srl. It received FDA 510(k) clearance on 2023-06-14 under approval number K231406. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearumTM HS?

ClearumTM HS is a medical device that received FDA 510(k) clearance on 2023-06-14. It is manufactured by Bellco Srl. The 510(k) number is K231406.

When was ClearumTM HS approved by the FDA?

ClearumTM HS received FDA 510(k) clearance on 2023-06-14, under approval number K231406.

What company makes ClearumTM HS?

ClearumTM HS is manufactured by Bellco Srl.

What is the FDA product code for ClearumTM HS?

The FDA product code for ClearumTM HS is KDI.

Other Devices by Bellco Srl

K160558RAPIDO HOLLOW-FIBRE DIALYZERS K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

Related Devices (Code: KDI)

K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl K160881Tablo ConsoleOutset Medical, Inc. K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.

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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