S3 CYCLIC RPM CONTROL— 510(k) K971520

Substantially Equivalent

Stoeckert Instrumente

FDA 510(k) clearance K971520 for S3 CYCLIC RPM CONTROL, Substantially Equivalent on 1997-09-10. Applicant: Stoeckert Instrumente.

Clearance details

Applicant: Stoeckert Instrumente
Product code: Code DWB
Advisory panel: Cardiovascular
Date received: 1997-04-25
Decision date: 1997-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code DWB

product code DWB

Death: 2
Total: 2

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.