The following data is part of a premarket notification filed by Medox Corp. with the FDA for Medox Champion Compact Nebulizer.
| Device ID | K954327 |
| 510k Number | K954327 |
| Device Name: | MEDOX CHAMPION COMPACT NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDOX CORP. 1400 VILLAGE WAY Santa Ana, CA 92705 |
| Contact | Edward J Buzby |
| Correspondent | Edward J Buzby MEDOX CORP. 1400 VILLAGE WAY Santa Ana, CA 92705 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-15 |
| Decision Date | 1995-12-19 |