NRK · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.1600
Classification
FDA Product Code
NRK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 874.1600
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The home test for loss of the sense of smell is packaged in a small carton which contains (1) an instruction book, (2) a booklet containing twelve micorencapsulated smell strips, each on a separate page, with instructions for scoring the test and an answer key, and (3) a physician information card. The device is intended for screening neurological disorder.