ERM-101— 510(k) K781407

Substantially Equivalent

Cynergy

FDA 510(k) clearance K781407 for ERM-101, Substantially Equivalent on 1978-09-27. Applicant: Cynergy.

Clearance details

Applicant: Cynergy
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1978-08-14
Decision date: 1978-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.