ARC— 510(k) K934669

Substantially Equivalent

Medelec , Ltd.

FDA 510(k) clearance K934669 for ARC, Substantially Equivalent on 1994-04-26. Applicant: Medelec , Ltd..

Clearance details

Applicant: Medelec , Ltd.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 1993-09-29
Decision date: 1994-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Surrey, England Gu22 9ju, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.