The following data is part of a premarket notification filed by American Bantex Corp. with the FDA for American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi And B9100, 6 Psi.
| Device ID | K041963 |
| 510k Number | K041963 |
| Device Name: | AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | AMERICAN BANTEX CORP. 994 NORTH MAIN STREET Bountiful, UT 84010 |
| Contact | Tracy S Best |
| Correspondent | Tracy S Best AMERICAN BANTEX CORP. 994 NORTH MAIN STREET Bountiful, UT 84010 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-21 |
| Decision Date | 2004-10-20 |
| Summary: | summary |