LIFESCOPE 6 OEC-6102— 510(k) K841501

Substantially Equivalent

Nihon Kohden America, Inc.

FDA 510(k) clearance K841501 for LIFESCOPE 6 OEC-6102, Substantially Equivalent on 1984-08-28. Applicant: Nihon Kohden America, Inc..

Clearance details

Applicant: Nihon Kohden America, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1984-04-10
Decision date: 1984-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foothill, CA, 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.