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510(k) K950101

RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR by Marquette Electronics, Inc. — Product Code CBS

K950101 is an FDA 510(k) premarket notification submitted by Marquette Electronics, Inc. for the device "RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR". The FDA issued a decision of Substantially Equivalent on March 21, 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. Marquette Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
January 11, 1995
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 Marquette Electronics, Inc.

  • K971868 — IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM (November 13, 1997)
  • K971683 — WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET (October 22, 1997)
  • K972199 — SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS (September 25, 1997)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K962827 — ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) (February 24, 1997)
  • K964750 — EAGLE 4000 PATIENT MONITOR (February 21, 1997)
  • K962551 — CARDIOSERV S (November 19, 1996)
  • K960272 — EAGLE 3000/3100 PATIENT MONITOR (October 2, 1996)
  • K960418 — EAGLE PATIENT MONITOR (October 2, 1996)

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)
  • 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