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 |