The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vmt Gentle-haler.
| Device ID | K842988 |
| 510k Number | K842988 |
| Device Name: | VMT GENTLE-HALER |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | VORTRAN MEDICAL TECHNOLOGY 1, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-08-07 |