510(k) K911229

PHOENIX DIGITAL EEG SYSTEM by Dantec Medical, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 30, 1991
Date Received: March 20, 1991
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 Dantec Medical, Inc.

K960503 — DANTEC DUET (September 16, 1996)
K950314 — DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) (March 25, 1996)
K953999 — DANTEC DA CAPO (November 21, 1995)
K926363 — MULTI-DOP S (June 19, 1995)
K931801 — MULTI-DOP X (June 14, 1995)
K930458 — MULTI-DOP L (February 3, 1995)
K932059 — NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE (October 4, 1994)
K934580 — DANTEC 13R45 BAR ELECTRODE (September 26, 1994)
K931966 — DANTEC DISPOSABLE CONCENTRIC NEEDLE (March 30, 1994)
K931923 — DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) (November 9, 1993)

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)