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510(k) K943458

AS/3 AIRWAY MODULE by Datex Division Instrumentarium Corp. — Product Code CBS

K943458 is an FDA 510(k) premarket notification submitted by Datex Division Instrumentarium Corp. for the device "AS/3 AIRWAY MODULE". The FDA issued a decision of Substantially Equivalent on February 14, 1995. 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 Division Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1995
Date Received
July 18, 1994
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 Division Instrumentarium Corp.

  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)
  • K961247 — AS/3 LIGHT MONITOR (October 23, 1996)
  • K945234 — AS/3 MEMORY MODULE, M0MEM (January 27, 1995)
  • K933156 — DATEX AS/3 PATIENT MONITOR (December 30, 1994)
  • K933285 — DATEX AS/3 TM ANAESTHESIA MONITOR (November 14, 1994)
  • K943456 — AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT (October 17, 1994)
  • K923172 — ANAESTHESIA RECORD KEEPER (August 9, 1994)
  • K935477 — AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD (August 1, 1994)
  • K943457 — AS/3 PRESSURE TEMPERATURE MODULE, M-PT (July 27, 1994)
  • K933284 — AS/3 TM NETWORK (July 11, 1994)

Other clearances for product code CBS

  • K974903 — GAS MODULE II, MODEL 0998-00-0143 (March 13, 1998)
  • K953795 — VITALMAX 4100 (July 1, 1996)
  • K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV (May 3, 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)
  • 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