510(k) K946094

CADWELL EASY AMBULATORY EEG by Cadwell Laboratories, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 12, 1995
Date Received: December 14, 1994
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 Cadwell Laboratories, Inc.

K061706 — CADWELL EASYNET OXIMETER MODULE (March 5, 2007)
K061705 — CADWELL EASYNET NASAL PRESSURE MODULE (November 21, 2006)
K042350 — TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR (November 3, 2004)
K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)
K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)
K971214 — KILOWIN (June 11, 1998)
K962457 — TWO-CHANNEL PREAMPLIFIER (January 13, 1997)
K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (January 13, 1997)
K933808 — EEG CUP ELECTRODE (December 29, 1994)

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)