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510(k) K960490

AS/3 COMPACT AIRWAY MODULE M-CAIOV by Datex Medical Instrumentation, Inc. — Product Code CBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1996
Date Received
February 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1620
Review Panel
AN
Submission Type

Other clearances by Datex Medical Instrumentation, Inc.

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  • K912530 — CARDIOCAP II(TM) (September 5, 1991)

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  • K932389 — 8100 ANESTHETIC AGENT MONITOR (December 3, 1993)
  • K905754 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (June 17, 1991)
  • K896629 — NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR (February 12, 1990)
  • K896216 — HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A (January 16, 1990)