Biotres— 510(k) K222017
Substantially EquivalentBiotricity
FDA 510(k) clearance K222017 for Biotres, Substantially Equivalent on 2022-07-28. Applicant: Biotricity. Device class: 2.
Clearance details
- Applicant
- Biotricity
- Product code
- Code MWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood City, CA, US
Recent devices under product code MWJ
view allMore clearances from Biotricity
view allAdverse events under product code MWJ
product code MWJ- 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.