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FDA 510(k)

DK*300 VOLUMETRIC INFUSION CONTROLLER

K-Number: K843254 · 1984-10-11

ApplicantDeka Research & Development Corp.
Decision Date1984-10-11
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DK*300 VOLUMETRIC INFUSION CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 1984-10-11 under 510(k) number K843254. 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 DK*300 VOLUMETRIC INFUSION CONTROLLER?

DK*300 VOLUMETRIC INFUSION CONTROLLER is a medical device that received FDA 510(k) clearance on 1984-10-11. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K843254.

When did DK*300 VOLUMETRIC INFUSION CONTROLLER receive FDA 510(k) clearance?

DK*300 VOLUMETRIC INFUSION CONTROLLER received FDA 510(k) clearance on 1984-10-11, under 510(k) number K843254.

Who is the listed applicant for DK*300 VOLUMETRIC INFUSION CONTROLLER?

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

What is the FDA product code for DK*300 VOLUMETRIC INFUSION CONTROLLER?

The FDA product code for DK*300 VOLUMETRIC INFUSION CONTROLLER is LDR.

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Other records listing Deka Research & Development Corp. 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.

K250930twiist systemK250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionK241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionK243354Remunity SystemK172601Next Generation iBOTK124018AMIA AUTOMATED PD SYSTEM

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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 DevelopmentK153760Volumetric Infusion ControllerDEKA Research & DevelopmentK963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.

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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