DeviceClearance

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration— 510(k) K153391

Substantially Equivalent

Sophono, Inc.

FDA 510(k) clearance K153391 for Sophono Bone Conduction Systems (S) Configuration and (M) Configuration, Substantially Equivalent on 2016-06-16. Applicant: Sophono, Inc..

Clearance details

Applicant
Sophono, Inc.
Product code
Code LXB
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boulder, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LXB

product code LXB
Injury
2,334
Total
2,334

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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