FDA 510(k)

SyntrFuge System

Numéro K : K203800 · 2021-07-02

DemandeurSyntr Health Technologies, Inc.

Date de décision2021-07-02

Code produitMUU

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

SyntrFuge System is the device name listed in this FDA 510(k) record. The listed applicant is Syntr Health Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K203800. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SyntrFuge System?

SyntrFuge System is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Syntr Health Technologies, Inc.. The 510(k) number is K203800.

When did SyntrFuge System receive FDA 510(k) clearance?

SyntrFuge System received FDA 510(k) clearance on 2021-07-02, under 510(k) number K203800.

Who is the listed applicant for SyntrFuge System?

The FDA 510(k) record lists Syntr Health Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SyntrFuge System?

The FDA product code for SyntrFuge System is MUU.

Essais cliniques associés

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Source officielle

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