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510(k) K863675

CALIBRATION GAS FOR SERVO GAS MONITOR 120 by Siemens Elema AB — Product Code BXK

K863675 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "CALIBRATION GAS FOR SERVO GAS MONITOR 120". The FDA issued a decision of Substantially Equivalent on November 3, 1986. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1986
Date Received
September 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas, Calibration (Specified Concentration)
Device Class
Class I
Regulation Number
868.6400
Review Panel
AN
Submission Type

Other clearances by Siemens Elema AB

  • K023354 — COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (September 5, 2003)
  • K010923 — KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E (January 23, 2002)
  • K010925 — SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E (December 18, 2001)
  • K002137 — CATHCOR DESKTOP (October 5, 2000)
  • K001315 — MODIFICATION TO KION ANESTHESIA SYSTEM (May 26, 2000)
  • K970839 — SERVO VENTILATOR 300A (October 14, 1997)
  • K960168 — SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 (October 25, 1996)
  • K960010 — SERVO VENTILATOR 300 COMPUTER INTERFACE (October 25, 1996)
  • K872278 — SIEMENS O2-AIR MIXER 965 (September 3, 1987)
  • K871354 — SERVO VENTILATOR 900 C/D (July 21, 1987)

Other clearances for product code BXK

  • K954804 — LUNG DIFFUSION MIXTURES (January 25, 1996)
  • K954803 — BLOOD GAS MIXTURES (January 25, 1996)
  • K954542 — LUNG DIFFUSION MIXTURE (December 22, 1995)
  • K952838 — MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES (September 19, 1995)
  • K953934 — MED-TECH LUNG DIFFUSION MIXTURE (September 18, 1995)
  • K953208 — MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES (July 20, 1995)
  • K944998 — CALIBRATION GAS (February 3, 1995)
  • K944812 — CLINICAL BLOOD GAS MIXTURE (February 1, 1995)
  • K942866 — CLINICAL BLOOD GAS MIXTURE (September 1, 1994)
  • K932874 — BLOOD GAS MIXTURE (January 27, 1994)

FDA data resources