510(k) K862919
- Device
- Transpirator(tm) Mt-1000 Personal Humidifier
- Applicant
- TRANSPIRATOR TECHNOLOGICS, INC.
- 510(k) number
- K862919
- Product code
- KFZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-07
- Date received
- 1986-08-01
- Regulation
- 868.5460
- Classification name
- Humidifier, Non-Direct Patient Interface (Home-Use)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN E PORCELLA
- Address
- 265 Davidson Ave. Somerset NJ US 08873 08873
FDA Registration Numbers#
- 3017886332
- 3014810929
- 3004569415
- 3015968545
- 3033011342
- 3022528821
- 3014442295
- 3003751839
- 3002798681
- 3017555752
- 3004134948
- 3008789244
- 3028172072
- 3016068274
- 3008395118
- 3006547005
- 3005587132
- 3005980667
- 3010408344
- 3010834934
- 3012208431
- 3034397208
- 1000190272
- 8030673
- 3009537407
- 3008687634
- 9616085
- 1217805
- 3007816986
- 9710644
- 3011187730
- 3006606984
- 3033905868
- 3010683450
- 3015191173
- 3022929665
- 3013689783
- 1530881
- 3026282195
- 3021244152
- 3014153468
- 3010402691
- 3020751316
- 3017222105
- 3011919098
- 3022568093
- 3003862188
- 8030607
- 3004264602
- 3010169226
- 3014561131
- 3017429279
- 3029915531
- 3008567544
- 3003902679
- 3004116032
- 3008115001
- 1720839
- 3006169981
- 3013521677
- 3009529084
- 3010186069
- 1836161
- 1422443
- 3010405299
- 2110540
- 3038214786
- 3016610659
- 2028807
- 9710567
- 3013550220
- 3004139830
- 3007360714
- 3008496560
- 1220479
- 3017265430
- 3017618922
- 3007770329
- 1043899
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KFZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950116 | THERASTEAM PERSONAL STEAM INHALER | Kaz, Inc. | 1995-02-10 |
| K915603 | VIROTHERM HUMIDIFIER | Virotherm Laboratory | 1992-10-22 |
| K894734 | RHINOTHERM ULTRA 2 | Twinmed Products, Inc. | 1990-02-16 |
| K871661 | WH150 ROOM HUMIDIFIER | Associated Mills, Inc. | 1987-06-15 |
| K871189 | SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 | Sunbeam Appliance Service Co. | 1987-05-08 |
| K862171 | MP-500 ELECTRONIC NEBULIZER | The Timeter Group | 1986-07-14 |
| K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER | Associated Mills, Inc. | 1986-06-05 |
| K851220 | SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 | Northern Electric Co. Div. of Sunbeam Corp. | 1985-09-17 |
| K852283 | THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE | Thermix, Inc. | 1985-07-30 |
| K850711 | INHALATION THERAPY NEBULIZER DEVICE | Med USA | 1985-06-05 |
| K842275 | ULTRASONIC COOL SPRAY HUMIDIFIER | Sunbeam Corp. | 1984-08-14 |
| K840118 | RHINOTHERM | Ascot Pharmaceuticals, Inc. | 1984-04-13 |
| K831646 | SONIC MIST ULTRASONIC HUMIDIFIER | Douglas Products | 1983-07-12 |
| K830896 | HUMIDIFIER, WITH OR WITHOUT ADAPTER | Airlife, Inc. | 1983-04-18 |
| K811161 | HUMIDIFIER W/ OR W/OUT ADAPTOR | Airlife, Inc. | 1981-06-24 |