ORT · Class II · 21 CFR 882.1400

FDA Product Code ORT: Burst Suppression Detection Software For Electroencephalograph

Automatically Mark Or Identify Electroencephalograph Waveforms For Rhythmic Patterns Of Burst Suppression In Order To Aid In Identification Of Such Events And Help In The Review And Annotation Of Prolonged Eeg Traces; Software Can Also Quantify Simple Characteristics Of The Burst Suppression Such As Inter-burst Interval Or Count; All Output Subject To Verification By Qualified User.

1
Total
1
Cleared
306d
Avg days
2010
Since

FDA 510(k) Cleared Burst Suppression Detection Software For Electroencephalograph Devices (Product Code ORT)

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About Product Code ORT - Regulatory Context