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510(k) K051666

GAV - GENERAL ANAESTHETIC VAPORIZER by General Anaesthetic Services Limited — Product Code CAD

K051666 is an FDA 510(k) premarket notification submitted by General Anaesthetic Services Limited for the device "GAV - GENERAL ANAESTHETIC VAPORIZER". The FDA issued a decision of Substantially Equivalent on August 23, 2005. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2005
Date Received
June 22, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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)
  • K060331 — SIGMA ALPHA VAPORIZER (May 10, 2006)
  • K053564 — KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 (March 3, 2006)
  • 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