Milieve (YPS-301BD)— 510(k) K233751

Substantially Equivalent

Soterix Medical, Inc.

FDA 510(k) clearance K233751 for Milieve (YPS-301BD), Substantially Equivalent on 2024-06-03. Applicant: Soterix Medical, Inc..

Clearance details

Applicant
Soterix Medical, Inc.
Product code
Code PCC
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Woodbridge, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code PCC

product code PCC
Other
1
Total
1

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.