BlueStar and BlueStar Rx— 510(k) K230813
Substantially EquivalentWelldoc, Inc.
FDA 510(k) clearance K230813 for BlueStar and BlueStar Rx, Substantially Equivalent on 2023-07-28. Applicant: Welldoc, Inc..
Clearance details
- Applicant
- Welldoc, Inc.
- Product code
- Code NDC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
Adverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
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.