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510(k) K093501

ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION by Spacelabs Medical, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2009
Date Received
November 12, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Spacelabs Medical, Inc.

  • K120616 — SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 (March 29, 2012)
  • K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) (November 2, 2011)
  • K102422 — SPACELABS MEDICAL PATIENT MONITORS (December 7, 2010)
  • 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)
  • K050605 — SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (May 3, 2005)

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