CANTATA EMG/EVOKED RESPONSE SYSTEM— 510(k) K896567

Substantially Equivalent

Dantec Medical, Inc.

FDA 510(k) clearance K896567 for CANTATA EMG/EVOKED RESPONSE SYSTEM, Substantially Equivalent on 1990-02-16. Applicant: Dantec Medical, Inc..

Clearance details

Applicant: Dantec Medical, Inc.
Product code: Code GWF
Advisory panel: Neurology
Date received: 1989-11-20
Decision date: 1990-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

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Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.