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NAS

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Tympanometer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1090
Medical specialty
Ear, Nose, Throat
Flags
Third-party review eligible
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RecordFirmDate
Otowave 302 Portable Tympanometer (K171265)Amplivox, Ltd.2017-07-28
Otowave 202 Portable Tympanometer (K150163)Amplivox, Ltd.2015-04-23

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Every clearance here is in the API, with alerts when new ones post.