Sunbeam Evaporative Humidifier 663 & 664

Q: What is the product code of K851220?

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.

FDA 510(k) K851220 · Northern Electric Co. Div. of Sunbeam Corp.

Substantially Equivalent

510(k) numberK851220

Submission

Device name: Sunbeam Evaporative Humidifier 663 & 664
Applicant: Northern Electric Co. Div. of Sunbeam Corp.
Chicago, IL, US
Received: March 26, 1985
Decision date: September 17, 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)	Device	Applicant	Decision
K950116	Therasteam Personal Steam InhalerKFZ · Traditional	Kaz, Inc.	02/10/1995SE
K915603	Virotherm HumidifierKFZ · Traditional	Virotherm Laboratory	10/22/1992SE
K894734	Rhinotherm Ultra 2KFZ · Traditional	Twinmed Products, Inc.	02/16/1990SE
K871661	WH150 Room HumidifierKFZ · Traditional	Associated Mills, Inc.	06/15/1987SE
K871189	Sunbeam Dura-Vap Warm Steam Vaporizer Model 1380KFZ · Traditional	Sunbeam Appliance Service Co.	05/08/1987SE
K862919	Transpirator(Tm) MT-1000 Personal HumidifierKFZ · Traditional	Transpirator Technologics, Inc.	11/07/1986SE
K862171	MP-500 Electronic NebulizerKFZ · Traditional	The Timeter Group	07/14/1986SE
K862042	SH20, SH30 & SH50 Ultrasonic HumidifierKFZ · Traditional	Associated Mills, Inc.	06/05/1986SE
K852283	Thermix Inc. Nasotherm II Personal Steam MachineKFZ · Traditional	Thermix, Inc.	07/30/1985SE
K850711	Inhalation Therapy Nebulizer DeviceKFZ · Traditional	Med USA	06/05/1985SE

More from Med USA

510(k)	Device	Decision
K860118	Sunbeam Ultrasonic Denture Cleaner Model 4220EFT · Traditional	04/17/1986SE
K852593	Sunbeam Dental Care Center, Model No. 6273EFS · Traditional	07/24/1985SE
K852279	Sunbeam Rechargeable Toothbrush Model # 4201JEQ · Traditional	07/01/1985SE

Questions and answers

When was Sunbeam Evaporative Humidifier 663 & 664 cleared by the FDA?

Sunbeam Evaporative Humidifier 663 & 664 (K851220) received a 510(k) decision of Substantially Equivalent on September 17, 1985, 175 days after the submission was received.

What is the product code of K851220?

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.