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510(k) K133355

CADWELL FLEX EEG/PSG by Cadwell Industries, Inc. — Product Code GWQ

K133355 is an FDA 510(k) premarket notification submitted by Cadwell Industries, Inc. for the device "CADWELL FLEX EEG/PSG". The FDA issued a decision of Substantially Equivalent on January 29, 2014. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Cadwell Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2014
Date Received
October 31, 2013
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 Industries, Inc.

  • K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electr (June 26, 2026)
  • K250851 — Hypnos (369054-200) (December 14, 2025)
  • K242424 — Bluebird Single-Use Respiratory Effort Belt (December 18, 2024)
  • K230415 — Cadwell Guardian (August 17, 2023)
  • K201819 — Cadwell Apollo System (September 29, 2020)
  • K192624 — ApneaTrak (February 20, 2020)
  • K190760 — Cadwell Bolt Software (November 23, 2019)
  • K181466 — Cadwell Zenith System (September 1, 2018)
  • K180269 — Cadwell Apollo System (July 17, 2018)
  • K162199 — Cascade IOMAX Intraoperative Monitor (March 2, 2017)

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