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510(k) K001315

MODIFICATION TO KION ANESTHESIA SYSTEM by Siemens Elema AB — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2000
Date Received
April 26, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
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)
  • K970839 — SERVO VENTILATOR 300A (October 14, 1997)
  • K960010 — SERVO VENTILATOR 300 COMPUTER INTERFACE (October 25, 1996)
  • K960168 — SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 (October 25, 1996)
  • K872278 — SIEMENS O2-AIR MIXER 965 (September 3, 1987)
  • K871354 — SERVO VENTILATOR 900 C/D (July 21, 1987)
  • K871829 — SIEMENS DRY AIR COMPRESSOR (June 15, 1987)

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