BlueStar and BlueStar Rx— 510(k) K230813

Name: FDA 510(k) clearance K230813
Creator: U.S. Food and Drug Administration
Published: 2023-07-28

Substantially Equivalent

Welldoc, Inc.

FDA 510(k) clearance K230813 for BlueStar and BlueStar Rx, Substantially Equivalent on 2023-07-28. Applicant: Welldoc, Inc.. Device class: 2.

Clearance details

Applicant: Welldoc, Inc.
Product code: Code NDC
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2023-03-24
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.