K031686 is an FDA 510(k) clearance for the AEROMIST LT, MODEL HCS15004. This device is classified as a Compressor, Air, Portable (Class II - Special Controls, product code BTI).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on January 21, 2004, 233 days after receiving the submission on June 2, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6250.
| 510(k) Number | K031686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2003 |
| Decision Date | January 21, 2004 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTI — Compressor, Air, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.6250 |