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510(k) K942545

SIGMA ELITE by Penlon , Ltd. — Product Code CAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1995
Date Received
May 31, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaporizer, Anesthesia, Non-Heated
Device Class
Class II
Regulation Number
868.5880
Review Panel
AN
Submission Type

Other clearances by Penlon , Ltd.

  • K061102 — PRIMA ANAESTHESIA MACHINE (July 28, 2006)
  • K041076 — DELTA T (August 9, 2004)
  • K010318 — PRIMA OXYGEN MONITOR (July 23, 2001)
  • K010317 — AV 800 VENTILATOR (July 23, 2001)
  • K002343 — SIGMA DELTA (June 8, 2001)
  • K961468 — QUIK-FIL VAPORIZER KEYED FILLER (July 16, 1996)
  • K960944 — PPV VAPORIZER (MODIFICATION) (April 2, 1996)
  • K953179 — CLM LARYNGOSCOPE (October 6, 1995)
  • K936046 — SIGMA ELITE (November 4, 1994)
  • K902381 — PENLON BREATHING SYSTEM PRESSURE MONITOR (August 17, 1990)

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  • K110608 — SEVOFLURANE VAPORIZER ADAPTOR (July 20, 2011)
  • K060331 — SIGMA ALPHA VAPORIZER (May 10, 2006)
  • K053564 — KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 (March 3, 2006)
  • K051666 — GAV - GENERAL ANAESTHETIC VAPORIZER (August 23, 2005)
  • K042276 — D-VAPOR (September 23, 2004)
  • K041076 — DELTA T (August 9, 2004)
  • K031027 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (June 26, 2003)