Inhalation Therapy Nebulizer Device

FDA 510(k) K850711 · Med USA

Substantially Equivalent

510(k) numberK850711

Submission

Device name
Inhalation Therapy Nebulizer Device
Applicant
Med USA
Waltham, MA, US
Received
February 22, 1985
Decision date
June 5, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KFZ – Humidifier, Non-Direct Patient Interface (Home-Use)
Device class
Class I (low risk)
Regulation
21 CFR 868.5460
Specialty
Anesthesiology

Other 510(k)s with product code KFZ

510(k)DeviceApplicantDecision
K950116Therasteam Personal Steam InhalerKFZ · Traditional Kaz, Inc.02/10/1995SE
K915603Virotherm HumidifierKFZ · Traditional Virotherm Laboratory10/22/1992SE
K894734Rhinotherm Ultra 2KFZ · Traditional Twinmed Products, Inc.02/16/1990SE
K871661WH150 Room HumidifierKFZ · Traditional Associated Mills, Inc.06/15/1987SE
K871189Sunbeam Dura-Vap Warm Steam Vaporizer Model 1380KFZ · Traditional Sunbeam Appliance Service Co.05/08/1987SE
K862919Transpirator(Tm) MT-1000 Personal HumidifierKFZ · Traditional Transpirator Technologics, Inc.11/07/1986SE
K862171MP-500 Electronic NebulizerKFZ · Traditional The Timeter Group07/14/1986SE
K862042SH20, SH30 & SH50 Ultrasonic HumidifierKFZ · Traditional Associated Mills, Inc.06/05/1986SE
K851220Sunbeam Evaporative Humidifier 663 & 664KFZ · Traditional Northern Electric Co. Div. of Sunbeam Corp.09/17/1985SE
K852283Thermix Inc. Nasotherm II Personal Steam MachineKFZ · Traditional Thermix, Inc.07/30/1985SE

More from Thermix, Inc.

510(k)DeviceDecision
K896766TD-28 Disposable ElectrodeGXY · Traditional 03/14/1990SE
K862047Coagulator (8 Channel)KQG · Traditional 09/29/1986SE
K852492CoagulatorKQG · Traditional 08/13/1985SE
K841803A1 Systeme 8201/2GKL · Traditional 02/25/1985SE

Questions and answers

When was Inhalation Therapy Nebulizer Device cleared by the FDA?

Inhalation Therapy Nebulizer Device (K850711) received a 510(k) decision of Substantially Equivalent on June 5, 1985, 103 days after the submission was received.

What is the product code of K850711?

The FDA product code is KFZ – Humidifier, Non-Direct Patient Interface (Home-Use), a Class I (low risk) device regulated under 21 CFR 868.5460.