FDA 510(k)

Zeos Aqua Vision Pump and tube

K-Number: K192921 · 2020-10-09

Decision Date2020-10-09

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Zeos Aqua Vision Pump and tube is a medical device manufactured by Hemodia Sas. It received FDA 510(k) clearance on 2020-10-09 under approval number K192921. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeos Aqua Vision Pump and tube?

Zeos Aqua Vision Pump and tube is a medical device that received FDA 510(k) clearance on 2020-10-09. It is manufactured by Hemodia Sas. The 510(k) number is K192921.

When was Zeos Aqua Vision Pump and tube approved by the FDA?

Zeos Aqua Vision Pump and tube received FDA 510(k) clearance on 2020-10-09, under approval number K192921.

What company makes Zeos Aqua Vision Pump and tube?

Zeos Aqua Vision Pump and tube is manufactured by Hemodia Sas.

What is the FDA product code for Zeos Aqua Vision Pump and tube?

The FDA product code for Zeos Aqua Vision Pump and tube is HRX.

Other Devices by Hemodia Sas

K203480DOUBLEFLO system K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

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.