The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Heart Nebulizer #100609.
| Device ID | K963910 |
| 510k Number | K963910 |
| Device Name: | HEART NEBULIZER #100609 |
| 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 | 1996-09-30 |
| Decision Date | 1996-12-16 |