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HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL

DEN050007 Class II Post-NSE
Decision Date
2006-03-27
Sponsor / Applicant
Fmg Innovations, Inc.

Technical Specification

510(k) Submission ID DEN050007
Product Code NRK
Medical Specialty / Panel Ear, Nose, Throat
Regulation Citation 21 CFR 874.1600
Decision Date 2006-03-27
Clearance Pathway Post-NSE

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

HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL received FDA 510(k) clearance under submission number DEN050007, sponsored by Fmg Innovations, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2006-03-27.

Classification & Regulation

This clearance is catalogued under FDA product code NRK and 21 CFR 874.1600, within the Ear, Nose, Throat review panel as a Class II device.