CARDIO2 CTCKE— 510(k) K930253

Substantially Equivalent

Ergometrx, Inc.

FDA 510(k) clearance K930253 for CARDIO2 CTCKE, Substantially Equivalent on 1993-10-18. Applicant: Ergometrx, Inc..

Clearance details

Applicant: Ergometrx, Inc.
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 1993-01-19
Decision date: 1993-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findley, MN, US

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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

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.