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FDA 510(k)

SOLO MICROPUMP INSULIN DELIVERY SYSTEM

K-Number: K093364 · 2010-01-25

ApplicantMedingo , Ltd.
Decision Date2010-01-25
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOLO MICROPUMP INSULIN DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medingo , Ltd.. It received FDA 510(k) clearance on 2010-01-25 under 510(k) number K093364. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLO MICROPUMP INSULIN DELIVERY SYSTEM?

SOLO MICROPUMP INSULIN DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-25. The listed applicant is Medingo , Ltd.. The 510(k) number is K093364.

When did SOLO MICROPUMP INSULIN DELIVERY SYSTEM receive FDA 510(k) clearance?

SOLO MICROPUMP INSULIN DELIVERY SYSTEM received FDA 510(k) clearance on 2010-01-25, under 510(k) number K093364.

Who is the listed applicant for SOLO MICROPUMP INSULIN DELIVERY SYSTEM?

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

What is the FDA product code for SOLO MICROPUMP INSULIN DELIVERY SYSTEM?

The FDA product code for SOLO MICROPUMP INSULIN DELIVERY SYSTEM is LZG.

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 Medingo , 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.

K090245SOLO INSULIN PATCH PUMP

Related Devices (Code: LZG)

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.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, 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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