The following data is part of a premarket notification filed by Ems Handels Gesellschaft M.b.h. with the FDA for Sienna Ultimate Wireless Amplifier.
| Device ID | K171397 |
| 510k Number | K171397 |
| Device Name: | Sienna Ultimate Wireless Amplifier |
| Classification | Amplifier, Physiological Signal |
| Applicant | EMS Handels Gesellschaft M.b.H. Jochingergasse 1 Korneuburg, AT A-2100 |
| Contact | Ruzena Ortnerova |
| Correspondent | Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-11 |
| Decision Date | 2017-10-06 |
| Summary: | summary |