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510(k) K852283

THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE by Thermix, Inc. — Product Code KFZ

K852283 is an FDA 510(k) premarket notification submitted by Thermix, Inc. for the device "THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE". The FDA issued a decision of Substantially Equivalent on July 30, 1985. The device falls under product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), a Class I device regulated under 21 CFR 868.5460.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1985
Date Received
May 29, 1985
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 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)
  • K850711 — INHALATION THERAPY NEBULIZER DEVICE (June 5, 1985)

FDA data resources