The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Multistim Eco.
| Device ID | K162086 |
| 510k Number | K162086 |
| Device Name: | MultiStim ECO |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Contact | Christian Quass |
| Correspondent | Christian Quass PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2017-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223035320 | K162086 | 000 |
| 04048223027486 | K162086 | 000 |
| 04048223075975 | K162086 | 000 |
| 04048223075913 | K162086 | 000 |