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QANS (Quantitative Autonomic Nervous System) Monitoring System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142551

by Hhssystems, LLC

Identifiers

510(k) Number
K142551 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

QANS (Quantitative Autonomic Nervous System) Monitoring System by Hhssystems, LLC — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hhssystems, LLC

Sources (1)

  • FDA 510(k) K142551 24 fields · synced Jun 18, 2026