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510(k) K010728

HARMONE-SCHWARZER EEG SYSTEM by Stellate Systems — Product Code OLV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2001
Date Received
March 12, 2001
Clearance Type
Abbreviated
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 Stellate Systems

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  • K982351 — LUNA (July 29, 1998)
  • K955577 — ECLIPSE VERSION 3.0 (September 20, 1996)
  • K960273 — HARMONIE SENSA (April 4, 1996)
  • K912938 — RHYTHM (July 30, 1991)

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