Home / 510(k) Clearances / K862042

510(k) K862042

SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER by Associated Mills, Inc. — Product Code KFZ

K862042 is an FDA 510(k) premarket notification submitted by Associated Mills, Inc. for the device "SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER". The FDA issued a decision of Substantially Equivalent on June 5, 1986. The device falls under product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), a Class I device regulated under 21 CFR 868.5460. Associated Mills, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1986
Date Received
May 28, 1986
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 Associated Mills, Inc.

  • K901459 — DS60 TOOTHBRUSH SANITIZER (September 17, 1990)
  • K872327 — WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 (September 4, 1987)
  • K871661 — WH150 ROOM HUMIDIFIER (June 15, 1987)
  • K862041 — WM10, WM20, WM30 POWER MASSAGER (June 17, 1986)
  • K844396 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 (April 18, 1985)
  • K844397 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 (April 18, 1985)
  • K850362 — POLLENEX DIGITAL THERMOMETER T-125 (February 15, 1985)
  • K850363 — POLLENEX DIGITAL THERMOMETER T-225 (February 15, 1985)
  • K841095 — BP800, 850 1000 (August 24, 1984)
  • K841100 — HP-20, 30, 40, 50 & 60 (March 23, 1984)

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)
  • K851220 — SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (September 17, 1985)
  • K852283 — THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE (July 30, 1985)
  • K850711 — INHALATION THERAPY NEBULIZER DEVICE (June 5, 1985)

FDA data resources