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FDA 510(k)

DISETRONIC D-TRON INSULIN INFUSION PUMP

K-Number: K021725 · 2002-08-02

ApplicantDisetronic Medical Systems AG
Decision Date2002-08-02
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISETRONIC D-TRON INSULIN INFUSION PUMP 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 2002-08-02 under 510(k) number K021725. 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 DISETRONIC D-TRON INSULIN INFUSION PUMP?

DISETRONIC D-TRON INSULIN INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2002-08-02. The listed applicant is Disetronic Medical Systems AG. The 510(k) number is K021725.

When did DISETRONIC D-TRON INSULIN INFUSION PUMP receive FDA 510(k) clearance?

DISETRONIC D-TRON INSULIN INFUSION PUMP received FDA 510(k) clearance on 2002-08-02, under 510(k) number K021725.

Who is the listed applicant for DISETRONIC D-TRON INSULIN INFUSION PUMP?

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 DISETRONIC D-TRON INSULIN INFUSION PUMP?

The FDA product code for DISETRONIC D-TRON INSULIN INFUSION PUMP is LZG.

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Other records listing Disetronic Medical Systems AG 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.

K100704ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICEK070189ACCU-CHEK ULTRAFLEX INFUSION SETK063146ACCU-CHEK LINKASSISTK060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWAK042887ACCU-CHEK SPIRITK043000MODIFICATION TO D-TRONPLUS

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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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