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FDA 510(k)

DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK

K-Number: K922074 · 1993-01-22

ApplicantDanby Medical , Ltd.
Decision Date1993-01-22
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK is the device name listed in this FDA 510(k) record. The listed applicant is Danby Medical , Ltd.. It received FDA 510(k) clearance on 1993-01-22 under 510(k) number K922074. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK?

DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK is a medical device that received FDA 510(k) clearance on 1993-01-22. The listed applicant is Danby Medical , Ltd.. The 510(k) number is K922074.

When did DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK receive FDA 510(k) clearance?

DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK received FDA 510(k) clearance on 1993-01-22, under 510(k) number K922074.

Who is the listed applicant for DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK?

The FDA 510(k) record lists Danby Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK?

The FDA product code for DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK is FRN.

Related Clinical Trials

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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Other records listing Danby Medical , Ltd. 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.

K912914DANBY-DCR VOLUMETRIC INFUSION PUMP

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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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