The following data is part of a premarket notification filed by Ekom S.r.o. with the FDA for Dk50 Ds.
| Device ID | K091871 |
| 510k Number | K091871 |
| Device Name: | DK50 DS |
| Classification | Compressor, Air, Portable |
| Applicant | EKOM S.R.O. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden EKOM S.R.O. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2009-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521540811 | K091871 | 000 |
| 08586014621407 | K091871 | 000 |
| 08586014620295 | K091871 | 000 |
| 08586014625047 | K091871 | 000 |
| 08586014620301 | K091871 | 000 |