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510(k) K053599

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES by Spacelabs Medical, Inc. — Product Code CBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2006
Date Received
December 23, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1700
Review Panel
AN
Submission Type

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  • 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)
  • K050605 — SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (May 3, 2005)

Other clearances for product code CBR

  • K112173 — SPEACELABS MULTIGAS MODULE (October 5, 2011)
  • K954962 — SPACELABS MEDICAL MULTIGAS ANALYZER (May 31, 1996)
  • K904843 — OSCAR(TM) II CAPNOMETER & PULSE OXIMETER (April 9, 1991)
  • K853360 — N20 TEST (September 3, 1985)