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510(k) K863318

AEROSOL-T by Southmedic, Inc. — Product Code BZA

K863318 is an FDA 510(k) premarket notification submitted by Southmedic, Inc. for the device "AEROSOL-T". The FDA issued a decision of Substantially Equivalent on September 11, 1986. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Southmedic, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1986
Date Received
August 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
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)
  • 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 BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources