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EPIC ClearView System

DEN150004 Class I Direct
Decision Date
2016-07-15
Sponsor / Applicant
Epic Research & Diagnostics, Inc.

Technical Specification

510(k) Submission ID DEN150004
Product Code PNA
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1561
Decision Date 2016-07-15
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

EPIC ClearView System received FDA 510(k) clearance under submission number DEN150004, sponsored by Epic Research & Diagnostics, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-07-15.

Classification & Regulation

This clearance is catalogued under FDA product code PNA and 21 CFR 882.1561, within the Neurology review panel as a Class I device.