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510(k) K013046

COSMOS SYSTEM by Spacelabs Medical, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2002
Date Received
September 10, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Spacelabs Medical, Inc.

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  • K102422 — SPACELABS MEDICAL PATIENT MONITORS (December 7, 2010)
  • K093501 — ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION (November 24, 2009)
  • K082045 — MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (August 1, 2008)
  • K063490 — SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 (March 15, 2007)
  • K062095 — MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (September 29, 2006)
  • K062278 — SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 (September 19, 2006)
  • K060900 — SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES (June 23, 2006)
  • K053599 — SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (April 19, 2006)

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