Home / 510(k) Clearances / K002316

510(k) K002316

PHOENIX DIGITAL EEG by Axon Systems, Inc. — Product Code GWQ

K002316 is an FDA 510(k) premarket notification submitted by Axon Systems, Inc. for the device "PHOENIX DIGITAL EEG". The FDA issued a decision of Substantially Equivalent on October 26, 2000. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Axon Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2000
Date Received
July 31, 2000
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

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • 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)

FDA data resources