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510(k) K960490

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

K960490 is an FDA 510(k) premarket notification submitted by Datex Medical Instrumentation, Inc. for the device "AS/3 COMPACT AIRWAY MODULE M-CAIOV". The FDA issued a decision of Substantially Equivalent on May 3, 1996. The device falls under product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1620. Datex Medical Instrumentation, Inc. has at least 4 other 510(k) clearances on record.

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.

  • K955026 — AS/3 NMT MODULE (April 28, 1997)
  • K961063 — AS/3 CARDIAC OUTPUT & SVO2 MODULE (May 31, 1996)
  • K953006 — AS/3 NETWORK LINK (September 27, 1995)
  • K912530 — CARDIOCAP II(TM) (September 5, 1991)

Other clearances for product code CBS

  • K974903 — GAS MODULE II, MODEL 0998-00-0143 (March 13, 1998)
  • K953795 — VITALMAX 4100 (July 1, 1996)
  • K951366 — RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (August 2, 1995)
  • K950101 — RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR (March 21, 1995)
  • K943458 — AS/3 AIRWAY MODULE (February 14, 1995)
  • K942737 — POET IQ WITH FIVE AGENT CAPABILITY (February 9, 1995)
  • 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)

FDA data resources