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)

AA-1 SYSTEM

K-Number: K012530 · 2001-08-31

ApplicantNeurovision, Inc.
Decision Date2001-08-31
Product CodeHJT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AA-1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neurovision, Inc.. It received FDA 510(k) clearance on 2001-08-31 under 510(k) number K012530. The device is classified under product code HJT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AA-1 SYSTEM?

AA-1 SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-31. The listed applicant is Neurovision, Inc.. The 510(k) number is K012530.

When did AA-1 SYSTEM receive FDA 510(k) clearance?

AA-1 SYSTEM received FDA 510(k) clearance on 2001-08-31, under 510(k) number K012530.

Who is the listed applicant for AA-1 SYSTEM?

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

What is the FDA product code for AA-1 SYSTEM?

The FDA product code for AA-1 SYSTEM is HJT.

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

Related Devices (Code: HJT)

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.

K013110ANISEIKONIA INSPECTOROptical Diagnostics, 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.

↑