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FDA 510(k)

ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA

K-Number: K060876 · 2006-06-15

ApplicantDisetronic Medical Systems AG
Decision Date2006-06-15
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA 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 2006-06-15 under 510(k) number K060876. 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 ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA?

ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA is a medical device that received FDA 510(k) clearance on 2006-06-15. The listed applicant is Disetronic Medical Systems AG. The 510(k) number is K060876.

When did ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA receive FDA 510(k) clearance?

ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA received FDA 510(k) clearance on 2006-06-15, under 510(k) number K060876.

Who is the listed applicant for ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA?

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 ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA?

The FDA product code for ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA 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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