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510(k) K873194

SPECTRAMED RESPIRATORY GAS ANALYZER by Draeger Medical, Inc. — Product Code CBS

K873194 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "SPECTRAMED RESPIRATORY GAS ANALYZER". The FDA issued a decision of Substantially Equivalent on October 30, 1987. The device falls under product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1620. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1987
Date Received
August 13, 1987
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 Draeger Medical, Inc.

  • K121886 — SAVINA 300 SAVINA 300, COUNTRY VARIANTS (August 8, 2014)
  • K133886 — PERSEUS A500 (June 20, 2014)
  • K121999 — GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE (February 28, 2013)
  • K103035 — SMARTPILOT VIEW MODEL MK04500 (March 28, 2012)
  • K082600 — OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 57 (November 26, 2008)
  • K060705 — CARINA HOME (June 14, 2006)
  • K042607 — PRIMUS US (November 26, 2004)
  • K042419 — FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (October 8, 2004)
  • K042276 — D-VAPOR (September 23, 2004)
  • K042086 — FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (August 31, 2004)

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