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510(k) K840326

GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB by Siemens Elema AB — Product Code CAM

K840326 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB". The FDA issued a decision of Substantially Equivalent on June 7, 1984. The device falls under product code CAM (Yoke Assembly, Medical Gas), a Class I device regulated under 21 CFR 868.6885. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1984
Date Received
January 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Yoke Assembly, Medical Gas
Device Class
Class I
Regulation Number
868.6885
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 CAM

  • K935283 — YOKE ASSEMBLY MEDICAL GAS (March 11, 1994)
  • K851216 — PENOX DUAL FEED MANIFOLD (June 18, 1985)
  • K851217 — PENOX DUAL FLOW MINIFOLD (June 18, 1985)
  • K851215 — T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (June 18, 1985)
  • K851219 — FILL HOSE SAFETY ADAPTER (June 18, 1985)
  • K780365 — OXYGEN/NITROUS OXIDE OUTLET (March 30, 1978)
  • K770426 — OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE (March 15, 1977)

FDA data resources