Rhinotherm Ultra 2
FDA 510(k) K894734 · Twinmed Products, Inc.
510(k) numberK894734
Submission
- Device name
- Rhinotherm Ultra 2
- Applicant
- Twinmed Products, Inc.
Santa Monica, CA, US - Received
- July 24, 1989
- Decision date
- February 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| K851220 | Sunbeam Evaporative Humidifier 663 & 664KFZ · Traditional | Northern Electric Co. Div. of Sunbeam Corp. | 09/17/1985SE |
| 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 |
Questions and answers
When was Rhinotherm Ultra 2 cleared by the FDA?
Rhinotherm Ultra 2 (K894734) received a 510(k) decision of Substantially Equivalent on February 16, 1990, 207 days after the submission was received.
What is the product code of K894734?
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.