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510(k) K946094

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

K946094 is an FDA 510(k) premarket notification submitted by Cadwell Laboratories, Inc. for the device "CADWELL EASY AMBULATORY EEG". The FDA issued a decision of Substantially Equivalent on September 12, 1995. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Cadwell Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K933808 — EEG CUP ELECTRODE (December 29, 1994)

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