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FDA 510(k)

Volumetric Infusion Controller

K-Number: K153760 · 2016-10-03

Decision Date2016-10-03
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Volumetric Infusion Controller is a medical device manufactured by DEKA Research & Development. It received FDA 510(k) clearance on 2016-10-03 under approval number K153760. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Volumetric Infusion Controller?

Volumetric Infusion Controller is a medical device that received FDA 510(k) clearance on 2016-10-03. It is manufactured by DEKA Research & Development. The 510(k) number is K153760.

When was Volumetric Infusion Controller approved by the FDA?

Volumetric Infusion Controller received FDA 510(k) clearance on 2016-10-03, under approval number K153760.

What company makes Volumetric Infusion Controller?

Volumetric Infusion Controller is manufactured by DEKA Research & Development.

What is the FDA product code for Volumetric Infusion Controller?

The FDA product code for Volumetric Infusion Controller is LDR.

Other Devices by DEKA Research & Development

Related Devices (Code: LDR)

Official Source

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