SONIC MIST ULTRASONIC HUMIDIFIER
FDA 510(k) clearance K831646 · decided 1983-07-12
Clearance details
- K-number
- K831646
- Device name
- SONIC MIST ULTRASONIC HUMIDIFIER
- Applicant
- Douglas Products
- Decision
- Substantially Equivalent
- Date received
- 1983-05-19
- Decision date
- 1983-07-12
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- KFZ
- Device class
- 1
- Regulation number
- 868.5460
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THERASTEAM PERSONAL STEAM INHALER (K950116) | Kaz, Inc. | 1995-02-10 |
| VIROTHERM HUMIDIFIER (K915603) | Virotherm Laboratory | 1992-10-22 |
| RHINOTHERM ULTRA 2 (K894734) | Twinmed Products, Inc. | 1990-02-16 |
| WH150 ROOM HUMIDIFIER (K871661) | Associated Mills, Inc. | 1987-06-15 |
| SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 (K871189) | Sunbeam Appliance Service Co. | 1987-05-08 |
| TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER (K862919) | Transpirator Technologics, Inc. | 1986-11-07 |
| MP-500 ELECTRONIC NEBULIZER (K862171) | The Timeter Group | 1986-07-14 |
| SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER (K862042) | Associated Mills, Inc. | 1986-06-05 |
| SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (K851220) | Northern Electric Co. Div. of Sunbeam Corp. | 1985-09-17 |
| THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE (K852283) | Thermix, Inc. | 1985-07-30 |
| INHALATION THERAPY NEBULIZER DEVICE (K850711) | Med USA | 1985-06-05 |
| ULTRASONIC COOL SPRAY HUMIDIFIER (K842275) | Sunbeam Corp. | 1984-08-14 |
Recalls involving this device
No recalls on record reference this clearance.