The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Intermittent Signal Actuated Nebulizer (visan).
| Device ID | K873477 |
| 510k Number | K873477 |
| Device Name: | INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | VORTRAN MEDICAL TECHNOLOGY 1, INC. 1600 SACRAMENTO INN WAY SUITE 132 Sacramento, CA 95815 |
| Contact | Wong, M.d. |
| Correspondent | Wong, M.d. VORTRAN MEDICAL TECHNOLOGY 1, INC. 1600 SACRAMENTO INN WAY SUITE 132 Sacramento, CA 95815 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-31 |
| Decision Date | 1987-10-09 |