The following data is part of a premarket notification filed by Cadema Medical Products, Inc. with the FDA for Lung Aerosol Unit.
| Device ID | K800023 |
| 510k Number | K800023 |
| Device Name: | LUNG AEROSOL UNIT |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | CADEMA MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-07 |
| Decision Date | 1985-01-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00718175003244 | K800023 | 000 |
| 00718175001240 | K800023 | 000 |
| 00718175087633 | K800023 | 000 |
| 00879942070132 | K800023 | 000 |
| 00879942070118 | K800023 | 000 |
| 00879942070101 | K800023 | 000 |
| 00879942070125 | K800023 | 000 |