The following data is part of a premarket notification filed by Ekom S.r.o. with the FDA for Medical Compressor, Models Dk50 D And Dm.
| Device ID | K060781 |
| 510k Number | K060781 |
| Device Name: | MEDICAL COMPRESSOR, MODELS DK50 D AND DM |
| Classification | Compressor, Air, Portable |
| Applicant | EKOM S.R.O. 32884 DANAPOPLAR Dana Point, CA 92629 |
| Contact | Esther Saltz |
| Correspondent | Esther Saltz EKOM S.R.O. 32884 DANAPOPLAR Dana Point, CA 92629 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-22 |
| Decision Date | 2006-10-03 |
| Summary: | summary |