510(k) K863193

SENTINEL 4 EEG ANALYZER by Axon Systems, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 2, 1986
Date Received: August 19, 1986
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

Other clearances by Axon Systems, Inc.

K090838 — STIMULUS/DISSECTION INSTRUMENTS (July 20, 2009)
K062996 — DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES (January 12, 2007)
K062198 — SUNSPOTS PRE-GELLED SURFACE ELECTRODES (December 19, 2006)
K061639 — ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TC (November 1, 2006)
K061113 — ORTHOMON (May 23, 2006)
K050798 — ECLIPSE NEUROLOGICAL WORKSTATION (August 15, 2005)
K050194 — AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES (April 26, 2005)
K032741 — EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION (December 16, 2003)
K022785 — EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION (October 9, 2002)
K010697 — UNIQUE AMBULATORY EEG (June 6, 2001)

Other clearances for product code GWQ

K260455 — New Wave System (March 13, 2026)
K233403 — Flexset System (April 30, 2024)
K231366 — Neuronaute Plus (November 9, 2023)
K221959 — Q21 (August 31, 2023)
K231457 — SPARK Scan (August 18, 2023)
K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
K230073 — Okti (February 9, 2023)
K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
K220056 — iSyncWave (August 10, 2022)
K212788 — Seer Home (June 16, 2022)