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510(k) K945993

VAPOFIL by Southmedic, Inc. — Product Code CAD

K945993 is an FDA 510(k) premarket notification submitted by Southmedic, Inc. for the device "VAPOFIL". The FDA issued a decision of Substantially Equivalent on February 22, 1995. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Southmedic, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1995
Date Received
November 18, 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 Southmedic, Inc.

  • K222511 — Oxy2Pro (November 21, 2023)
  • K131410 — CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH (January 13, 2014)
  • K101953 — SMDIA-1000 (January 7, 2011)
  • K014211 — OXYARM CO2 (June 11, 2002)
  • K923265 — FUNNEL ADAPTOR (March 18, 1993)
  • K863318 — AEROSOL-T (September 11, 1986)
  • K861839 — VAPOFIL (May 21, 1986)
  • K860545 — VAPORIZER SPACER (April 17, 1986)
  • K843993 — ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 (November 15, 1984)

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)
  • 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)

FDA data resources