SEP-10S PLUS, AND SP-12S PRO.— 510(k) K010937

Substantially Equivalent

Viltechmeda

FDA 510(k) clearance K010937 for SEP-10S PLUS, AND SP-12S PRO., Substantially Equivalent on 2001-06-25. Applicant: Viltechmeda.

Clearance details

Applicant: Viltechmeda
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2001-03-29
Decision date: 2001-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vilnius, LT

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.