K091871 is an FDA 510(k) clearance for the DK50 DS. This device is classified as a Compressor, Air, Portable (Class II - Special Controls, product code BTI).
Submitted by Ekom S.R.O. (Bonita Springs, US). The FDA issued a Cleared decision on October 23, 2009, 122 days after receiving the submission on June 23, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6250.
| 510(k) Number | K091871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2009 |
| Decision Date | October 23, 2009 |
| Days to Decision | 122 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTI — Compressor, Air, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.6250 |