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510(k) K892854

ANESTHETIC AGENT MONITOR by Criticare Systems, Inc. — Product Code CBQ

K892854 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "ANESTHETIC AGENT MONITOR". The FDA issued a decision of Substantially Equivalent on Oct 13, 1989. The device falls under product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)), a Class II device regulated under 21 CFR 868.1500. Criticare Systems, Inc. has 21 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 13, 1989
Date Received
Apr 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class
Class II
Regulation Number
868.1500
Review Panel
AN
Submission Type
510(k)

Other clearances by Criticare Systems, Inc.

  • K101602 — VITAL SIGNS MONITOR (Sep 1, 2010)
  • K091050 — 506CN PATIENT MONITOR (May 27, 2009)
  • K042569 — 8600 VITAL SIGNS MONITOR (Sep 29, 2004)
  • K030613 — VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 (Apr 17, 2003)
  • K022435 — 507EL VITAL SIGNS MONITOR (Aug 14, 2002)
  • K012059 — 8100/8500 VITAL SIGNS MONITOR (Aug 1, 2001)
  • K001020 — 8100 VITAL SIGNS MONITOR (Apr 28, 2000)
  • K000276 — MPT 24 AND VITAL VIEW 24 (Mar 1, 2000)
  • K961223 — MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS (Dec 10, 1996)
  • K944860 — SCHOLAR PATIENT MONITOR (Jun 20, 1995)

Other clearances for product code CBQ

  • K040917 — PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (Apr 29, 2004)
  • K994188 — MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (May 19, 2000)
  • K962648 — OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (Jan 17, 1997)
  • K931439 — OHMEDA MODEL 5330 ANESTHETIC MONITOR (Oct 19, 1993)
  • K926451 — DATASCOPE MULTINEX II (Aug 25, 1993)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (Jul 22, 1993)
  • K922876 — AS/3 COP MODULE (Jul 21, 1993)
  • K923276 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (Jul 21, 1993)
  • K930303 — DATASCOPE MULTINEX ID PLUS (Jun 16, 1993)
  • K914295 — ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (Apr 10, 1992)

FDA data resources