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FDA 510(k)

MINIMED PARADIGM INSULIN PUMP, MODEL 511

K-Number: K001829 · 2000-08-18

ApplicantMinimed, Inc.
Decision Date2000-08-18
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MINIMED PARADIGM INSULIN PUMP, MODEL 511 is the device name listed in this FDA 510(k) record. The listed applicant is Minimed, Inc.. It received FDA 510(k) clearance on 2000-08-18 under 510(k) number K001829. 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 MINIMED PARADIGM INSULIN PUMP, MODEL 511?

MINIMED PARADIGM INSULIN PUMP, MODEL 511 is a medical device that received FDA 510(k) clearance on 2000-08-18. The listed applicant is Minimed, Inc.. The 510(k) number is K001829.

When did MINIMED PARADIGM INSULIN PUMP, MODEL 511 receive FDA 510(k) clearance?

MINIMED PARADIGM INSULIN PUMP, MODEL 511 received FDA 510(k) clearance on 2000-08-18, under 510(k) number K001829.

Who is the listed applicant for MINIMED PARADIGM INSULIN PUMP, MODEL 511?

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

What is the FDA product code for MINIMED PARADIGM INSULIN PUMP, MODEL 511?

The FDA product code for MINIMED PARADIGM INSULIN PUMP, MODEL 511 is FRN.

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Other records listing Minimed, 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.

K031541PARADIGMPAL, MODEL MMT-7330K031390MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712K030531MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METERK021974MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311K010377MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385K001828PARADIGM 1.5ML RESERVOIR, MODEL 326

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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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