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510(k) K851220

SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 by Northern Electric Co. Div. of Sunbeam Corp. — Product Code KFZ

K851220 is an FDA 510(k) premarket notification submitted by Northern Electric Co. Div. of Sunbeam Corp. for the device "SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664". The FDA issued a decision of Substantially Equivalent on September 17, 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. Northern Electric Co. Div. of Sunbeam Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1985
Date Received
March 26, 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 by Northern Electric Co. Div. of Sunbeam Corp.

  • K860118 — SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 (April 17, 1986)
  • K852593 — SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 (July 24, 1985)
  • K852279 — SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 (July 1, 1985)

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)
  • K852283 — THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE (July 30, 1985)
  • K850711 — INHALATION THERAPY NEBULIZER DEVICE (June 5, 1985)

FDA data resources