Panels › Anesthesiology › Product code KFZ · Class 1
Humidifier, Non-Direct Patient Interface (Home-Use)
Regulation 868.5460
0510(k)s in 12 months (20 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in KFZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Airlife, Inc. | 2 | 0 |
| Associated Mills, Inc. | 2 | 0 |
| Kaz, Inc. | 1 | 1 |
| Mistogen Equipment Co. | 2 | 0 |
| Ascot Pharmaceuticals, Inc. | 1 | 0 |
| Bigwall Enterprises | 0 | 1 |
| Cardinal Health Inc. | 0 | 1 |
| Douglas Products | 1 | 0 |
| Hankscraft Div. of Gerber Products Co. | 1 | 0 |
| Med USA | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 1995 | K950116 | THERASTEAM PERSONAL STEAM INHALER Kaz, Inc. | KFZ |
| Oct 22, 1992 | K915603 | VIROTHERM HUMIDIFIER Virotherm Laboratory | KFZ |
| Feb 16, 1990 | K894734 | RHINOTHERM ULTRA 2 Twinmed Products, Inc. | KFZ |
| Jun 15, 1987 | K871661 | WH150 ROOM HUMIDIFIER Associated Mills, Inc. | KFZ |
| May 8, 1987 | K871189 | SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 Sunbeam Appliance Service Co. | KFZ |
| Nov 7, 1986 | K862919 | TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER Transpirator Technologics, Inc. | KFZ |
| Jul 14, 1986 | K862171 | MP-500 ELECTRONIC NEBULIZER The Timeter Group | KFZ |
| Jun 5, 1986 | K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER Associated Mills, Inc. | KFZ |
| Sep 17, 1985 | K851220 | SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 Northern Electric Co. Div. of Sunbeam Corp. | KFZ |
| Jul 30, 1985 | K852283 | THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE Thermix, Inc. | KFZ |
| Jun 5, 1985 | K850711 | INHALATION THERAPY NEBULIZER DEVICE Med USA | KFZ |
| Aug 14, 1984 | K842275 | ULTRASONIC COOL SPRAY HUMIDIFIER Sunbeam Corp. | KFZ |
| Apr 13, 1984 | K840118 | RHINOTHERM Ascot Pharmaceuticals, Inc. | KFZ |
| Jul 12, 1983 | K831646 | SONIC MIST ULTRASONIC HUMIDIFIER Douglas Products | KFZ |
| Apr 18, 1983 | K830896 | HUMIDIFIER, WITH OR WITHOUT ADAPTER Airlife, Inc. | KFZ |
| Jun 24, 1981 | K811161 | HUMIDIFIER W/ OR W/OUT ADAPTOR Airlife, Inc. | KFZ |
| Mar 20, 1981 | K810335 | RESPIRIZER Respirizer Co., Div. Campillary Systems, Inc. | KFZ |
| Jun 11, 1979 | K790966 | ULTRASONIC HUMIDIFIER Hankscraft Div. of Gerber Products Co. | KFZ |
| Oct 16, 1978 | K781591 | NEBULIZER/HUMIDIFIER MODEL EH 147B Mistogen Equipment Co. | KFZ |
| Aug 11, 1976 | K760341 | HUMIDIFIER, ELECTRONIC (EH147) Mistogen Equipment Co. | KFZ |
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