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510(k) K871189

SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 by Sunbeam Appliance Service Co. — Product Code KFZ

K871189 is an FDA 510(k) premarket notification submitted by Sunbeam Appliance Service Co. for the device "SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380". The FDA issued a decision of Substantially Equivalent on May 8, 1987. 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
May 8, 1987
Date Received
March 24, 1987
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)
  • 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)
  • K850711 — INHALATION THERAPY NEBULIZER DEVICE (June 5, 1985)

FDA data resources