510(k) K962447

EQUINOX DIGITAL EEG SYSTEM by Physiometrix, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 12, 1996
Date Received: June 24, 1996
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Full-Montage Standard Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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K970942 — MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM (June 2, 1997)
K970694 — MODEL 1700, HYDRO PREP (May 14, 1997)
K962157 — MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM (November 25, 1996)
K961609 — MODEL 1220, OR E-NET (54-62 CM) (May 10, 1996)

Other clearances for product code GWQ

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K231366 — Neuronaute Plus (November 9, 2023)
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K230073 — Okti (February 9, 2023)
K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
K220056 — iSyncWave (August 10, 2022)
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