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510(k) K811161

HUMIDIFIER W/ OR W/OUT ADAPTOR by Airlife, Inc. — Product Code KFZ

K811161 is an FDA 510(k) premarket notification submitted by Airlife, Inc. for the device "HUMIDIFIER W/ OR W/OUT ADAPTOR". The FDA issued a decision of Substantially Equivalent on June 24, 1981. The device falls under product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), a Class I device regulated under 21 CFR 868.5460. Airlife, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1981
Date Received
April 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Non-Direct Patient Interface (Home-Use)
Device Class
Class I
Regulation Number
868.5460
Review Panel
AN
Submission Type

Other clearances by Airlife, Inc.

  • K834573 — AQUA TRAP (March 5, 1984)
  • K834570 — VOLUME VENTILATOR CIRCUIT W/WATER 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 KFZ

  • K950116 — THERASTEAM PERSONAL STEAM INHALER (February 10, 1995)
  • K915603 — VIROTHERM HUMIDIFIER (October 22, 1992)
  • K894734 — RHINOTHERM ULTRA 2 (February 16, 1990)
  • K871661 — WH150 ROOM HUMIDIFIER (June 15, 1987)
  • K871189 — SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 (May 8, 1987)
  • K862919 — TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER (November 7, 1986)
  • K862171 — MP-500 ELECTRONIC NEBULIZER (July 14, 1986)
  • K862042 — SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER (June 5, 1986)
  • K851220 — SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (September 17, 1985)
  • K852283 — THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE (July 30, 1985)

FDA data resources