The following data is part of a premarket notification filed by Texas Medical Industries, Inc. with the FDA for Ultramist 2000.
| Device ID | K972657 |
| 510k Number | K972657 |
| Device Name: | ULTRAMIST 2000 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TEXAS MEDICAL INDUSTRIES, INC. 1409 INDUSTRIAL PARK Royse City, TX 75189 |
| Contact | Steve Harlow |
| Correspondent | Steve Harlow TEXAS MEDICAL INDUSTRIES, INC. 1409 INDUSTRIAL PARK Royse City, TX 75189 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-15 |
| Decision Date | 1998-02-02 |