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510(k) K854036

MANUAL VENTILATION ACCESSORY by Siemens Elema AB

K854036 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "MANUAL VENTILATION ACCESSORY". The FDA issued a decision of Substantially Equivalent on October 23, 1985. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1985
Date Received
August 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)

FDA data resources