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510(k) K042039

FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 by Cleveland Medical Devices, Inc. — Product Code OLV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2004
Date Received
July 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Standard Polysomnograph With Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

Other clearances by Cleveland Medical Devices, Inc.

  • K063872 — KINESIA (April 6, 2007)
  • K013863 — CRYSTAL MONITOR MODEL 16 (February 19, 2002)
  • 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)

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