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FDA PMA

Unknown Device

PMA Number: P990041 · 2021-12-21

ApplicantDiaSorin, Inc.
Decision Date2021-12-21
PMA NumberP990041
Product Code
Advisory CommitteeMI

Device Summary

Unknown Device is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-12-21. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Unknown Device?

Unknown Device is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is DiaSorin, Inc..

When did Unknown Device receive FDA 510(k) clearance?

The clearance date for Unknown Device can be found in the official FDA records.

Who is the listed applicant for Unknown Device?

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

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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