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FDA 510(k)

UNI-DOSE SYRINGE PUMP

K-Number: K920013 · 1992-05-13

ApplicantElectrochemical Drug Delivery, Inc.
Decision Date1992-05-13
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNI-DOSE SYRINGE PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Electrochemical Drug Delivery, Inc.. It received FDA 510(k) clearance on 1992-05-13 under 510(k) number K920013. 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 UNI-DOSE SYRINGE PUMP?

UNI-DOSE SYRINGE PUMP is a medical device that received FDA 510(k) clearance on 1992-05-13. The listed applicant is Electrochemical Drug Delivery, Inc.. The 510(k) number is K920013.

When did UNI-DOSE SYRINGE PUMP receive FDA 510(k) clearance?

UNI-DOSE SYRINGE PUMP received FDA 510(k) clearance on 1992-05-13, under 510(k) number K920013.

Who is the listed applicant for UNI-DOSE SYRINGE PUMP?

The FDA 510(k) record lists Electrochemical Drug Delivery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNI-DOSE SYRINGE PUMP?

The FDA product code for UNI-DOSE SYRINGE PUMP 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 Electrochemical Drug Delivery, Inc. 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.

K904619INFU.DISK

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

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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