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510(k) K811890

DISPOSABLE TRACH T OXYGENATOR by Airlife, Inc. — Product Code BZA

K811890 is an FDA 510(k) premarket notification submitted by Airlife, Inc. for the device "DISPOSABLE TRACH T OXYGENATOR". The FDA issued a decision of Substantially Equivalent on July 15, 1981. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Airlife, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1981
Date Received
July 1, 1981
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 Airlife, Inc.

  • K834570 — VOLUME VENTILATOR CIRCUIT W/WATER TRAP (March 5, 1984)
  • K834573 — AQUA TRAP (March 5, 1984)
  • K834077 — SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN (December 12, 1983)
  • K833196 — VOLUME VENTILATOR CIRCUIT-NEBULIZER (November 3, 1983)
  • K833197 — TRACH SWIVE/CONNECTOR (October 28, 1983)
  • K832725 — DUAL DIAL VENTURI STYLE MASK (September 20, 1983)
  • K831246 — WHISTLER IN-LINE PRESSURE RELEASE VALVE (July 26, 1983)
  • K830895 — SINGLE USE NEBULIZER, ADJUST. AIR- (April 28, 1983)
  • K830896 — HUMIDIFIER, WITH OR WITHOUT ADAPTER (April 18, 1983)
  • K821129 — AIRLIFE NEBULIZER HEATER (May 18, 1982)

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