The following data is part of a premarket notification filed by Syva Co. with the FDA for Syntevent Atomizer/nebulizer Aerosol.
| Device ID | K822625 |
| 510k Number | K822625 |
| Device Name: | SYNTEVENT ATOMIZER/NEBULIZER AEROSOL |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-30 |
| Decision Date | 1982-10-13 |