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510(k) K023354

COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E by Siemens Elema AB — Product Code BTI

K023354 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E". The FDA issued a decision of Substantially Equivalent on September 5, 2003. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2003
Date Received
October 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

Other clearances by Siemens Elema AB

  • 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)
  • 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)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources