Soundwave Hearing, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Soundwave Hearing, LLC - FDA 510(k) Cleared Devices
Recent clearances: Sontro® OTC Hearing Aids (AI)
1
Total
1
Cleared
0
Denied
Soundwave Hearing, LLC has 1 FDA 510(k) cleared medical devices. Based in Oak Brook, US.
Last cleared in 2023. Active since 2023. Primary specialty: Ear, Nose, Throat.
Browse the FDA 510(k) cleared devices submitted by Soundwave Hearing, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Rook Quality Systems, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Soundwave Hearing, LLC
1 devices