The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Venti-gentle-haler(tm).
| Device ID | K933915 |
| 510k Number | K933915 |
| Device Name: | VENTI-GENTLE-HALER(TM) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST., SUITE 354 Sacramento, CA 95819 |
| Contact | Gordon A Wong |
| Correspondent | Gordon A Wong VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST., SUITE 354 Sacramento, CA 95819 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-10 |
| Decision Date | 1993-10-28 |