meddevicedb.com FDA Device Reference

NSS-2 System

DEN170018 Class II Direct
Decision Date
2017-11-15
Sponsor / Applicant
Innovative Health Solutions (Ihs), Inc.

Technical Specification

510(k) Submission ID DEN170018
Product Code PZR
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5896
Decision Date 2017-11-15
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

NSS-2 System received FDA 510(k) clearance under submission number DEN170018, sponsored by Innovative Health Solutions (Ihs), 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 2017-11-15.

Classification & Regulation

This clearance is catalogued under FDA product code PZR and 21 CFR 882.5896, within the Neurology review panel as a Class II device.