BiWaze Clear System— 510(k) K231728
Substantially EquivalentAbmrc, LLC
FDA 510(k) clearance K231728 for BiWaze Clear System, Substantially Equivalent on 2024-04-08. Applicant: Abmrc, LLC.
Clearance details
- Applicant
- Abmrc, LLC
- Product code
- Code NHJ
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eagan, MN, US
Adverse events under product code NHJ
product code NHJ- Death
- 7
- Total
- 7
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.