QANS (Quantitative Autonomic Nervous System) Monitoring System— 510(k) K142551

Substantially Equivalent

Hhssystems, LLC

FDA 510(k) clearance K142551 for QANS (Quantitative Autonomic Nervous System) Monitoring System, Substantially Equivalent on 2015-04-16. Applicant: Hhssystems, LLC.

Clearance details

Applicant: Hhssystems, LLC
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2014-09-10
Decision date: 2015-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suffern, NY, 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.