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FDA 510(k)

Volumetric Infusion Controller

K-Number: K153760 · 2016-10-03

ApplicantDEKA Research & Development
Decision Date2016-10-03
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Volumetric Infusion Controller is the device name listed in this FDA 510(k) record. The listed applicant is DEKA Research & Development. It received FDA 510(k) clearance on 2016-10-03 under 510(k) 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. The listed applicant is DEKA Research & Development. The 510(k) number is K153760.

When did Volumetric Infusion Controller receive FDA 510(k) clearance?

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

Who is the listed applicant for Volumetric Infusion Controller?

The FDA 510(k) record lists DEKA Research & Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Volumetric Infusion Controller?

The FDA product code for Volumetric Infusion Controller is LDR.

Other records listing DEKA Research & Development 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: LDR)

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.

K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development CorporationK232316DEKA Infusion System, DEKA Administration SetDeka Research and Development

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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