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510(k) K972502

SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 by Spacelabs Medical, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1998
Date Received
July 3, 1997
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

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  • K102422 — SPACELABS MEDICAL PATIENT MONITORS (December 7, 2010)
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  • 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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