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FDA 510(k)

HMB32 Dialysis Solution

K-Number: K212052 · 2021-07-23

ApplicantHaemopharm Biofluids S.R.L.
Decision Date2021-07-23
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HMB32 Dialysis Solution is the device name listed in this FDA 510(k) record. The listed applicant is Haemopharm Biofluids S.R.L.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K212052. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HMB32 Dialysis Solution?

HMB32 Dialysis Solution is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Haemopharm Biofluids S.R.L.. The 510(k) number is K212052.

When did HMB32 Dialysis Solution receive FDA 510(k) clearance?

HMB32 Dialysis Solution received FDA 510(k) clearance on 2021-07-23, under 510(k) number K212052.

Who is the listed applicant for HMB32 Dialysis Solution?

The FDA 510(k) record lists Haemopharm Biofluids S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HMB32 Dialysis Solution?

The FDA product code for HMB32 Dialysis Solution is KPO.

Related Devices (Code: KPO)

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.

K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLCK233213NxStage PureFlow SolutionNxstage Medical, Inc.

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.

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