HARMONIE SYSTEM— 510(k) K083577

Substantially Equivalent

Stellate Systems

FDA 510(k) clearance K083577 for HARMONIE SYSTEM, Substantially Equivalent on 2011-08-29. Applicant: Stellate Systems. Device class: 2.

Clearance details

Applicant: Stellate Systems
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2008-12-03
Decision date: 2011-08-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Montreal, Quebec, CA

Download summary PDF View on FDA.gov ↗

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Recalls naming K083577

K-number listed on FDA's recall record

Z-1080-2013 — Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,Class II·Terminated·Stellate Systems·20090406

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083577.

Data sourced from openFDA. This site is unofficial and independent of the FDA.