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 |