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 a medical device manufactured by Haemopharm Biofluids S.R.L.. It received FDA 510(k) clearance on 2021-07-23 under approval 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. It is manufactured by Haemopharm Biofluids S.R.L.. The 510(k) number is K212052.
When was HMB32 Dialysis Solution approved by the FDA?
HMB32 Dialysis Solution received FDA 510(k) clearance on 2021-07-23, under approval number K212052.
What company makes HMB32 Dialysis Solution?
HMB32 Dialysis Solution is manufactured by Haemopharm Biofluids S.R.L..
What is the FDA product code for HMB32 Dialysis Solution?
The FDA product code for HMB32 Dialysis Solution is KPO.
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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.