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510(k) K890446

ANESTHETIC GAS MONITOR by Bruel & Kjaer Instruments, Inc. — Product Code CBS

K890446 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer Instruments, Inc. for the device "ANESTHETIC GAS MONITOR". The FDA issued a decision of Substantially Equivalent on August 11, 1989. The device falls under product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1620. Bruel & Kjaer Instruments, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1989
Date Received
January 27, 1989
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 Bruel & Kjaer Instruments, Inc.

  • K901881 — VIBROMETRY SYSTEM (May 31, 1991)
  • K827380 — SCANNER TYPE 1846 (July 9, 1982)
  • K827409 — REAL TIME ULTRASOUND SCANNER 1849 (July 9, 1982)

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)
  • 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)

FDA data resources