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510(k) K161027

Cadwell AmpliScan by Cadwell Industries, Inc. — Product Code OMA

K161027 is an FDA 510(k) premarket notification submitted by Cadwell Industries, Inc. for the device "Cadwell AmpliScan". The FDA issued a decision of Substantially Equivalent on November 8, 2016. The device falls under product code OMA (Amplitude-Integrated 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
November 8, 2016
Date Received
April 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplitude-Integrated Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

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 OMA

  • K192889 — Neo (January 30, 2020)
  • K163644 — Nihon Kohden QP-160AK EEG Trend Program (May 19, 2017)
  • K152301 — Background Pattern Classification [BPc(TM)] (June 3, 2016)
  • K130238 — NIHON KOHDEN AE-918P NEURO UNIT (March 4, 2015)
  • K131789 — CEREBRALOGIK- AEEG (December 27, 2013)
  • K123079 — OLYMPIC BRAINZ MONITOR (May 8, 2013)
  • K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AN (March 16, 2012)
  • K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM (July 9, 2010)
  • K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)
  • K081551 — TWIN NEUROTRAC-III (December 24, 2008)

FDA data resources