WH150 Room Humidifier
FDA 510(k) K871661 · Associated Mills, Inc.
510(k) numberK871661
Submission
- Device name
- WH150 Room Humidifier
- Applicant
- Associated Mills, Inc.
Chicago, IL, US - Received
- April 28, 1987
- Decision date
- June 15, 1987
- 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
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| 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 |
| 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 |
More from Med USA
| 510(k) | Device | Decision |
|---|---|---|
| K901459 | DS60 Toothbrush SanitizerMCF · Traditional | 09/17/1990SE |
| K872327 | Whirlpool Aerator WB700, WB800, WB900, WB975ILJ · Traditional | 09/04/1987SE |
| K862041 | WM10, WM20, WM30 Power MassagerISA · Traditional | 06/17/1986SE |
| K862042 | SH20, SH30 & SH50 Ultrasonic HumidifierKFZ · Traditional | 06/05/1986SE |
| K844397 | Pollenex Digital Sphygmomanometer BP-4000DSK · Traditional | 04/18/1985SE |
| K844396 | Pollenex Digital Sphygmomanometer BP-2000DSK · Traditional | 04/18/1985SE |
| K850363 | Pollenex Digital Thermometer T-225FLL · Traditional | 02/15/1985SE |
| K850362 | Pollenex Digital Thermometer T-125FLL · Traditional | 02/15/1985SE |
| K841095 | BP800, 850 1000DXN · Traditional | 08/24/1984SE |
| K841100 | HP-20, 30, 40, 50 & 60IRT · Traditional | 03/23/1984SE |
Questions and answers
When was WH150 Room Humidifier cleared by the FDA?
WH150 Room Humidifier (K871661) received a 510(k) decision of Substantially Equivalent on June 15, 1987, 48 days after the submission was received.
What is the product code of K871661?
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.