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FDA 510(k)

MODIFICATION TO D-TRONPLUS

K-Number: K043000 · 2004-12-01

ApplicantDisetronic Medical Systems AG
Decision Date2004-12-01
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO D-TRONPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Disetronic Medical Systems AG. It received FDA 510(k) clearance on 2004-12-01 under 510(k) number K043000. 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 MODIFICATION TO D-TRONPLUS?

MODIFICATION TO D-TRONPLUS is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Disetronic Medical Systems AG. The 510(k) number is K043000.

When did MODIFICATION TO D-TRONPLUS receive FDA 510(k) clearance?

MODIFICATION TO D-TRONPLUS received FDA 510(k) clearance on 2004-12-01, under 510(k) number K043000.

Who is the listed applicant for MODIFICATION TO D-TRONPLUS?

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

What is the FDA product code for MODIFICATION TO D-TRONPLUS?

The FDA product code for MODIFICATION TO D-TRONPLUS is LZG.

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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

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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