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FDA 510(k)

MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP

K-Number: K931549 · 1993-10-12

ApplicantY
Decision Date1993-10-12
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K931549. 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 MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP?

MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Y. The 510(k) number is K931549.

When did MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP receive FDA 510(k) clearance?

MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP received FDA 510(k) clearance on 1993-10-12, under 510(k) number K931549.

Who is the listed applicant for MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP?

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

What is the FDA product code for MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP?

The FDA product code for MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP is FRN.

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Other records listing Y 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.

K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERK960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSK953225IVAC BALL VALCE ADMIN. SETSK934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSK940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETK931550EZ ADMINISTRATION SET

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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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