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FDA 510(k)

Zeos Aqua Vision Pump and tube

K-Number: K192921 · 2020-10-09

ApplicantHemodia Sas
Decision Date2020-10-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zeos Aqua Vision Pump and tube is the device name listed in this FDA 510(k) record. The listed applicant is Hemodia Sas. It received FDA 510(k) clearance on 2020-10-09 under 510(k) 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. The listed applicant is Hemodia Sas. The 510(k) number is K192921.

When did Zeos Aqua Vision Pump and tube receive FDA 510(k) clearance?

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

Who is the listed applicant for Zeos Aqua Vision Pump and tube?

The FDA 510(k) record lists Hemodia Sas as the applicant. This does not by itself establish the device manufacturer.

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 records listing Hemodia Sas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC

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.

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