Milieve (YPS-301BD)— 510(k) K233751
Substantially EquivalentSoterix Medical, Inc.
FDA 510(k) clearance K233751 for Milieve (YPS-301BD), Substantially Equivalent on 2024-06-03. Applicant: Soterix Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Soterix Medical, Inc.
- Product code
- Code PCC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5891
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodbridge, NJ, US
Recent devices under product code PCC
view allMore clearances from Soterix Medical, Inc.
view allAdverse 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.