CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)— 510(k) K223290

Substantially Equivalent

Sentiar, Inc.

FDA 510(k) clearance K223290 for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02), Substantially Equivalent on 2023-07-14. Applicant: Sentiar, Inc..

Clearance details

Applicant: Sentiar, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-10-26
Decision date: 2023-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.