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510(k) K110608

SEVOFLURANE VAPORIZER ADAPTOR by Piramal Critcal Care, Inc (Formerly Minrad, Inc) — Product Code CAD

K110608 is an FDA 510(k) premarket notification submitted by Piramal Critcal Care, Inc (Formerly Minrad, Inc) for the device "SEVOFLURANE VAPORIZER ADAPTOR". The FDA issued a decision of Substantially Equivalent on July 20, 2011. 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
July 20, 2011
Date Received
March 3, 2011
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 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)
  • 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)
  • K012924 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (January 30, 2002)

FDA data resources