Wavely Diagnostics, Inc.

Address:2319 North 45th Street, Suite 107,Seattle,WA,98103,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tester, Auditory Impedance, Exempt (PTO) (2)

Premarket Exempt

Yes

Clear

Wavely Ear Tip - 00860007953705 Catalog Number : 1300-05

Device Description : The Wavely Ear Tip is an accessory to the Wavely Middle Ear Fluid Scanner. The The Wavely Ear Tip is an accessory to the Wavely Middle Ear Fluid Scanner. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.

Device Class :

Duns Number: 116723050

Premarket Exempt : Yes

Product Code : PTO

Prescription Use : No

Device Count : 5

WavelyDx Middle Ear Fluid CMD iOS Application - 00860007953712 Catalog Number : SWA-1262

Device Description : The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD i The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in conjunction with the Wavely Ear Tip. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that maybe associated with acute ear infection.

Device Class : 2

Duns Number: 116723050

Premarket Exempt : Yes

Product Code : PTO

Prescription Use : No

Device Count : 1

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