CONSULTIVA REPORT STATION, MODEL RS-1— 510(k) K031248

Substantially Equivalent

Miramedica, Inc.

FDA 510(k) clearance K031248 for CONSULTIVA REPORT STATION, MODEL RS-1, Substantially Equivalent on 2003-06-20. Applicant: Miramedica, Inc..

Clearance details

Applicant: Miramedica, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2003-04-18
Decision date: 2003-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Gatos, CA, US

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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.