510(k) K013863

CRYSTAL MONITOR MODEL 16 by Cleveland Medical Devices, Inc. — Product Code OMC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 19, 2002
Date Received: November 21, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Reduced- 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 user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

Other clearances by Cleveland Medical Devices, Inc.

K063872 — KINESIA (April 6, 2007)
K042039 — FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 (November 17, 2004)
K001110 — CRYSTAL-EEG MODEL 15 (July 5, 2000)
K970672 — CRYSTAL-EEG MODEL 10 (MODEL 10) (May 22, 1997)
K964690 — LIBERTY VALVE (March 21, 1997)
K962591 — FOOT WEIGHT ALARM (December 4, 1996)
K954670 — PRESSORE MONITOR (October 30, 1995)

Other clearances for product code OMC

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K251726 — SignalNED System (Model RE) (September 3, 2025)
K243185 — REMI Remote EEG Monitoring System (March 21, 2025)
K242930 — Natus BrainWatch System (November 19, 2024)
K232779 — QUEX ED; QUEX S (October 11, 2024)
K242306 — SignalNED System (Model RE) (September 4, 2024)
K230933 — REMI Remote EEG Monitoring System (June 30, 2023)
K223628 — NEBA® Compact EEG2R Mobile Headset (March 2, 2023)
K221563 — Neurosteer EEG Recorder (October 24, 2022)
K203827 — REMI (March 29, 2021)