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FDA PMA

Acute coronary syndrome event detector

PMA Number: P150009 · 2024-08-14

ApplicantAvertix Medical, Inc.
Decision Date2024-08-14
PMA NumberP150009
Product CodeQBI
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Acute coronary syndrome event detector is the device name listed in this FDA 510(k) record. The listed applicant is Avertix Medical, Inc.. It received FDA 510(k) clearance on 2024-08-14. The device is classified under product code QBI. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Acute coronary syndrome event detector?

Acute coronary syndrome event detector is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Avertix Medical, Inc..

When did Acute coronary syndrome event detector receive FDA 510(k) clearance?

The clearance date for Acute coronary syndrome event detector can be found in the official FDA records.

Who is the listed applicant for Acute coronary syndrome event detector?

The FDA 510(k) record lists Avertix Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acute coronary syndrome event detector?

The FDA product code for Acute coronary syndrome event detector is QBI.

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_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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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