ANS SYSTEM— 510(k) K101016

Substantially Equivalent

Caird Technology

FDA 510(k) clearance K101016 for ANS SYSTEM, Substantially Equivalent on 2011-01-28. Applicant: Caird Technology.

Clearance details

Applicant: Caird Technology
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2010-04-12
Decision date: 2011-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

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.