BlueStar Rx— 510(k) K203434

Substantially Equivalent

Welldoc, Inc.

FDA 510(k) clearance K203434 for BlueStar Rx, Substantially Equivalent on 2021-09-08. Applicant: Welldoc, Inc..

Clearance details

Applicant: Welldoc, Inc.
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 2020-11-23
Decision date: 2021-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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.