Home / 510(k) Clearances / K061639

510(k) K061639

ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON by Axon Systems, Inc. — Product Code GWF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 1, 2006
Date Received: June 12, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Stimulator, Electrical, Evoked Response
Device Class: Class II
Regulation Number: 882.1870
Review Panel: NE
Submission Type

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)
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)
K002316 — PHOENIX DIGITAL EEG (October 26, 2000)

Other clearances for product code GWF

K252842 — SafeOp 3: Neural Informatix System (January 11, 2026)
K243982 — Nicolet EDX (January 22, 2025)
K243495 — Natus Ultrapro S100 (982A0594) (December 12, 2024)
K242345 — Delphi Stimulator (November 5, 2024)
K234092 — SafeOp 3: Neural Informatix Systeem (April 19, 2024)
K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (March 25, 2024)
K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (October 27, 2023)
K230415 — Cadwell Guardian (August 17, 2023)
K213849 — SafeOp 2: Neural Informatix System (March 9, 2022)
K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)