SyntrFuge System
K-Number: K203800 · 2021-07-02
ApplicantSyntr Health Technologies, Inc.
Decision Date2021-07-02
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SyntrFuge System is a medical device manufactured by Syntr Health Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-02 under approval number K203800. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SyntrFuge System?
SyntrFuge System is a medical device that received FDA 510(k) clearance on 2021-07-02. It is manufactured by Syntr Health Technologies, Inc.. The 510(k) number is K203800.
When was SyntrFuge System approved by the FDA?
SyntrFuge System received FDA 510(k) clearance on 2021-07-02, under approval number K203800.
What company makes SyntrFuge System?
SyntrFuge System is manufactured by Syntr Health Technologies, Inc..
What is the FDA product code for SyntrFuge System?
The FDA product code for SyntrFuge System is MUU.
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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.