Decision Date2022-09-14
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
V-HEPES PLUS is a medical device manufactured by Vitromed Langenfeld. It received FDA 510(k) clearance on 2022-09-14 under approval number K213293. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the V-HEPES PLUS?
V-HEPES PLUS is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Vitromed Langenfeld. The 510(k) number is K213293.
When was V-HEPES PLUS approved by the FDA?
V-HEPES PLUS received FDA 510(k) clearance on 2022-09-14, under approval number K213293.
What company makes V-HEPES PLUS?
V-HEPES PLUS is manufactured by Vitromed Langenfeld.
What is the FDA product code for V-HEPES PLUS?
The FDA product code for V-HEPES PLUS is MQL.
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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.