PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.— 510(k) K221803

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K221803 for PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress., Substantially Equivalent on 2022-07-18. Applicant: Sedecal., Sa..

Clearance details

Applicant: Sedecal., Sa.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2022-06-22
Decision date: 2022-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Algete, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.