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510(k) K850711

INHALATION THERAPY NEBULIZER DEVICE by Med USA — Product Code KFZ

K850711 is an FDA 510(k) premarket notification submitted by Med USA for the device "INHALATION THERAPY NEBULIZER DEVICE". The FDA issued a decision of Substantially Equivalent on June 5, 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. Med USA has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1985
Date Received
February 22, 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 Med USA

  • K896766 — TD-28 DISPOSABLE ELECTRODE (March 14, 1990)
  • K862047 — COAGULATOR (8 CHANNEL) (September 29, 1986)
  • K852492 — COAGULATOR (August 13, 1985)
  • K841803 — A1 SYSTEME 8201/2 (February 25, 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)
  • K851220 — SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (September 17, 1985)
  • K852283 — THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE (July 30, 1985)

FDA data resources