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FDA 510(k)

ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE

K-Number: K100704 · 2010-05-14

ApplicantDisetronic Medical Systems AG
Decision Date2010-05-14
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE 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 2010-05-14 under 510(k) number K100704. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE?

ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE is a medical device that received FDA 510(k) clearance on 2010-05-14. The listed applicant is Disetronic Medical Systems AG. The 510(k) number is K100704.

When did ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE receive FDA 510(k) clearance?

ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE received FDA 510(k) clearance on 2010-05-14, under 510(k) number K100704.

Who is the listed applicant for ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE?

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 FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE?

The FDA product code for ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE is FRN.

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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.

K070189ACCU-CHEK ULTRAFLEX INFUSION SETK063146ACCU-CHEK LINKASSISTK060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWAK042887ACCU-CHEK SPIRITK043000MODIFICATION TO D-TRONPLUSK033892ULTRAFLEX INFUSION SET

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Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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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