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510(k) K060331

SIGMA ALPHA VAPORIZER by Penlon Limited — Product Code CAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2006
Date Received
February 9, 2006
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 Limited

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  • K051222 — AV-S ANAESTHESIA VENTILATOR (September 23, 2005)

Other clearances for product code CAD

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  • K110608 — SEVOFLURANE VAPORIZER ADAPTOR (July 20, 2011)
  • 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)
  • K012924 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (January 30, 2002)