Zyno Z-800 Infusion System Model Z-800

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100705

by Zyno Medical, LLC

Identifiers

510(k) Number: K100705 FDA 510(k)
FDA Product Code: FRN FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 880.5725 FDA 510(k)
Regulation Number: 880.5725 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Zyno Z-800 Infusion System Model Z-800 is an infusion pump. It is a device used for infusion.

The Zyno Z-800 Infusion System Model Z-800 is supplied with instructions for use and is intended for use with Zyno Medical provided IV sets. It has a product code of FRN and is regulated under regulation number 880.5725. The device has been cleared with an FDA 510K authorization.

Frequently asked questions

What is the Zyno Z-800 Infusion System used for?

The Zyno Z-800 Infusion System is used for infusion, providing a controlled delivery of fluids or medications to patients.

Is the Zyno Z-800 Infusion System supplied with any accessories?

Yes, the Zyno Z-800 Infusion System is supplied with instructions for use and is intended for use with Zyno Medical provided IV sets.

What is the product code for the Zyno Z-800 Infusion System?

The product code for the Zyno Z-800 Infusion System is FRN, and it is regulated under regulation number 880.5725.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ZYNO MEDICAL Z-800 INSTRUCTIONS FOR USE MANUAL Pdf Download, Zyno Medical Z-800F Instructions For Use Manual, PDF Z-800 Infusion ump - InfuSystem, Zyno Medical Z-800 infusion pump INSTRUCTIONS FOR USE - Manualzz, PDF Z-800 Infusion ump - Right Way Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K100705	Class II	Active

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Manufacturer

Manufacturer: Zyno Medical, LLC

Sources (1)

FDA 510(k) K100705 24 fields · synced Sep 25, 2026