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FDA 510(k)

MICROJET QUARK, MODEL U100 OR U40

K-Number: K013807 · 2001-12-12

ApplicantCane S.R.L.
Decision Date2001-12-12
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICROJET QUARK, MODEL U100 OR U40 is the device name listed in this FDA 510(k) record. The listed applicant is Cane S.R.L.. It received FDA 510(k) clearance on 2001-12-12 under 510(k) number K013807. 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 MICROJET QUARK, MODEL U100 OR U40?

MICROJET QUARK, MODEL U100 OR U40 is a medical device that received FDA 510(k) clearance on 2001-12-12. The listed applicant is Cane S.R.L.. The 510(k) number is K013807.

When did MICROJET QUARK, MODEL U100 OR U40 receive FDA 510(k) clearance?

MICROJET QUARK, MODEL U100 OR U40 received FDA 510(k) clearance on 2001-12-12, under 510(k) number K013807.

Who is the listed applicant for MICROJET QUARK, MODEL U100 OR U40?

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

What is the FDA product code for MICROJET QUARK, MODEL U100 OR U40?

The FDA product code for MICROJET QUARK, MODEL U100 OR U40 is LZG.

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Related Devices (Code: LZG)

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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

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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