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510(k) K843993

ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 by Southmedic, Inc. — Product Code CAD

K843993 is an FDA 510(k) premarket notification submitted by Southmedic, Inc. for the device "ANAESLOCK THREE VAPORIZER INTERLOCK HVA003". The FDA issued a decision of Substantially Equivalent on November 15, 1984. 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
November 15, 1984
Date Received
October 11, 1984
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)
  • K945993 — VAPOFIL (February 22, 1995)
  • K923265 — FUNNEL ADAPTOR (March 18, 1993)
  • K863318 — AEROSOL-T (September 11, 1986)
  • K861839 — VAPOFIL (May 21, 1986)
  • K860545 — VAPORIZER SPACER (April 17, 1986)

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