CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL— 510(k) K851633

Substantially Equivalent

Eaton Medical Group

FDA 510(k) clearance K851633 for CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL, Substantially Equivalent on 1985-06-26. Applicant: Eaton Medical Group.

Clearance details

Applicant: Eaton Medical Group
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1985-04-18
Decision date: 1985-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eaton, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.