The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Aeromist Lt, Model Hcs15004.
| Device ID | K031686 |
| 510k Number | K031686 |
| Device Name: | AEROMIST LT, MODEL HCS15004 |
| Classification | Compressor, Air, Portable |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Andrea Haferkamp |
| Correspondent | Andrea Haferkamp MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-02 |
| Decision Date | 2004-01-21 |