The following data is part of a premarket notification filed by Cadema Medical Products, Inc. with the FDA for Aero-mist Nebulizer.
| Device ID | K881812 |
| 510k Number | K881812 |
| Device Name: | AERO-MIST NEBULIZER |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown, NY 10940 |
| Contact | Kathleen Bordoni |
| Correspondent | Kathleen Bordoni CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown, NY 10940 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-28 |
| Decision Date | 1988-07-18 |