Product code NAS— Ear, Nose, Throat

Otowave 202 Portable Tympanometer

Classification name
Tympanometer
Device class
Class 2
Regulation
21 CFR 874.1090
Advisory panel
Ear, Nose, Throat
Total cleared
2
First cleared
Most recent

Market context for product code NAS

FDA has cleared 2 devices under product code NAS between 2015 and 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NAS

Recent clearances under product code NAS

Data sourced from openFDA. This site is unofficial and independent of the FDA.