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510(k) K060331

SIGMA ALPHA VAPORIZER by Penlon Limited — Product Code CAD

K060331 is an FDA 510(k) premarket notification submitted by Penlon Limited for the device "SIGMA ALPHA VAPORIZER". The FDA issued a decision of Substantially Equivalent on May 10, 2006. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Penlon Limited has at least 2 other 510(k) clearances on record.

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

  • K053564 — KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 (March 3, 2006)
  • K051222 — AV-S ANAESTHESIA VENTILATOR (September 23, 2005)

Other clearances for product code CAD

  • K240375 — V80 Anesthetic Vaporizer (V80) (October 31, 2024)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K150167 — V60 Anesthetic Vaporizer (June 30, 2015)
  • 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)

FDA data resources