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WavelyDx Middle Ear Fluid CMD iOS Application

Wavely Diagnostics, Inc. · Model SWA-1488 · UDI-DI 00860007953767

PTO
0
510(k) clearances
0
Adverse events
0
Recalls
4
Facilities

Description

The WavelyDx Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, in conjunction with the WavelyDx Ear Tip accessory. The WavelyDx 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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.