The following data is part of a premarket notification filed by Aktormed Gmbh with the FDA for Soloasisst Ii, Voice Control.
| Device ID | K200473 |
| 510k Number | K200473 |
| Device Name: | SoloAsisst II, Voice Control |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | AKTORmed GmbH Borsigstraße 13 Barbing, DE 93092 |
| Contact | Andreas Mohr |
| Correspondent | Martin Dumberger Micro-Epsilon America 8120 Browneigh Road Raleigh, NC 27617 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-26 |
| Decision Date | 2020-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260463849141 | K200473 | 000 |
| 04260463848960 | K200473 | 000 |
| 04260463848953 | K200473 | 000 |
| 04260463848946 | K200473 | 000 |
| 04260463848823 | K200473 | 000 |