BIOSCOPE— 510(k) K923406

Substantially Equivalent

Biotronik, GmbH & Co.

FDA 510(k) clearance K923406 for BIOSCOPE, Substantially Equivalent on 1993-09-22. Applicant: Biotronik, GmbH & Co..

Clearance details

Applicant: Biotronik, GmbH & Co.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1992-07-10
Decision date: 1993-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

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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.