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FDA 510(k)

AIDERA DIASEND SYSTEM

K-Number: K101806 · 2010-12-07

ApplicantAidera AB
Decision Date2010-12-07
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIDERA DIASEND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aidera AB. It received FDA 510(k) clearance on 2010-12-07 under 510(k) number K101806. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIDERA DIASEND SYSTEM?

AIDERA DIASEND SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-07. The listed applicant is Aidera AB. The 510(k) number is K101806.

When did AIDERA DIASEND SYSTEM receive FDA 510(k) clearance?

AIDERA DIASEND SYSTEM received FDA 510(k) clearance on 2010-12-07, under 510(k) number K101806.

Who is the listed applicant for AIDERA DIASEND SYSTEM?

The FDA 510(k) record lists Aidera AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIDERA DIASEND SYSTEM?

The FDA product code for AIDERA DIASEND SYSTEM is MRZ.

Related Clinical Trials

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 Aidera AB 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.

K083221AIDERA DIASEND

Related Devices (Code: MRZ)

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.

K230718UTC 3mL Medication CartridgeGilero, LLCK220695Elite Biomedical Solutions Dose Request CordElite Biomedical SolutionsK201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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