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FDA 510(k)

ACCU-CHEK LINKASSIST

K-Number: K063146 · 2006-11-27

ApplicantDisetronic Medical Systems AG
Decision Date2006-11-27
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK LINKASSIST 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 2006-11-27 under 510(k) number K063146. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK LINKASSIST?

ACCU-CHEK LINKASSIST is a medical device that received FDA 510(k) clearance on 2006-11-27. The listed applicant is Disetronic Medical Systems AG. The 510(k) number is K063146.

When did ACCU-CHEK LINKASSIST receive FDA 510(k) clearance?

ACCU-CHEK LINKASSIST received FDA 510(k) clearance on 2006-11-27, under 510(k) number K063146.

Who is the listed applicant for ACCU-CHEK LINKASSIST?

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 LINKASSIST?

The FDA product code for ACCU-CHEK LINKASSIST is KZH.

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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.

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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 SETK060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWAK042887ACCU-CHEK SPIRITK043000MODIFICATION TO D-TRONPLUSK033892ULTRAFLEX INFUSION SET

View all 12 devices →

Related Devices (Code: KZH)

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.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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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