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FDA 510(k)

2008T BlueStar Hemodailysis Machine

K-Number: K222952 · 2022-10-27

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2022-10-27
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

2008T BlueStar Hemodailysis Machine is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2022-10-27 under approval number K222952. 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 2008T BlueStar Hemodailysis Machine?

2008T BlueStar Hemodailysis Machine is a medical device that received FDA 510(k) clearance on 2022-10-27. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K222952.

When was 2008T BlueStar Hemodailysis Machine approved by the FDA?

2008T BlueStar Hemodailysis Machine received FDA 510(k) clearance on 2022-10-27, under approval number K222952.

What company makes 2008T BlueStar Hemodailysis Machine?

2008T BlueStar Hemodailysis Machine is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for 2008T BlueStar Hemodailysis Machine?

The FDA product code for 2008T BlueStar Hemodailysis Machine is KDI.

Other Devices by Fresenius Medical Care Renal Therapies Group, LLC

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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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