Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AIDERA DIASEND

K-Number: K083221 · 2009-02-03

ApplicantAidera AB
Decision Date2009-02-03
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIDERA DIASEND is the device name listed in this FDA 510(k) record. The listed applicant is Aidera AB. It received FDA 510(k) clearance on 2009-02-03 under 510(k) number K083221. 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?

AIDERA DIASEND is a medical device that received FDA 510(k) clearance on 2009-02-03. The listed applicant is Aidera AB. The 510(k) number is K083221.

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

AIDERA DIASEND received FDA 510(k) clearance on 2009-02-03, under 510(k) number K083221.

Who is the listed applicant for AIDERA DIASEND?

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?

The FDA product code for AIDERA DIASEND 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K101806AIDERA DIASEND SYSTEM

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

View on FDA Database →

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

↑