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510(k) K760341

HUMIDIFIER, ELECTRONIC (EH147) by Mistogen Equipment Co. — Product Code KFZ

K760341 is an FDA 510(k) premarket notification submitted by Mistogen Equipment Co. for the device "HUMIDIFIER, ELECTRONIC (EH147)". The FDA issued a decision of Substantially Equivalent on August 11, 1976. The device falls under product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), a Class I device regulated under 21 CFR 868.5460. Mistogen Equipment Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1976
Date Received
July 30, 1976
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 Mistogen Equipment Co.

  • K801619 — MIST2GEN TEMPTROL 10 (August 4, 1980)
  • K781591 — NEBULIZER/HUMIDIFIER MODEL EH 147B (October 16, 1978)
  • K770984 — TA-2 TEMPERATURE ALARM (July 5, 1977)

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