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510(k) K112173

SPEACELABS MULTIGAS MODULE by Spacelabs Healthcare — Product Code CBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2011
Date Received
July 28, 2011
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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Other clearances for product code CBR

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  • K904843 — OSCAR(TM) II CAPNOMETER & PULSE OXIMETER (April 9, 1991)
  • K853360 — N20 TEST (September 3, 1985)