The following data is part of a premarket notification filed by Aktormed Gmbh with the FDA for Soloassist Ii.
| Device ID | K171947 |
| 510k Number | K171947 |
| Device Name: | SOLOASSIST II |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | AKTORmed GmbH Borsigstrabe 13 Barbing, DE 93092 |
| Contact | Andreas Mohr |
| Correspondent | Martin Dumberger Micro-Epsilon America 8120 Browneigh Road Raleigh, NC 93092 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-29 |
| Decision Date | 2018-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260463849776 | K171947 | 000 |
| 04260463840353 | K171947 | 000 |
| 04260463848229 | K171947 | 000 |
| 04260463844283 | K171947 | 000 |
| 04260463841985 | K171947 | 000 |
| 04260463840995 | K171947 | 000 |
| 04260463840971 | K171947 | 000 |
| 04260463840889 | K171947 | 000 |
| 04260463840681 | K171947 | 000 |
| 04260463840674 | K171947 | 000 |
| 04260463840667 | K171947 | 000 |
| 04260463840650 | K171947 | 000 |
| 04260463840544 | K171947 | 000 |
| 04260463843392 | K171947 | 000 |
| 04260463843576 | K171947 | 000 |
| 04260463849103 | K171947 | 000 |
| 04260463849073 | K171947 | 000 |
| 04260463848748 | K171947 | 000 |
| 04260463847741 | K171947 | 000 |
| 04260463847734 | K171947 | 000 |
| 04260463846904 | K171947 | 000 |
| 04260463843897 | K171947 | 000 |
| 04260463843651 | K171947 | 000 |
| 04260463843644 | K171947 | 000 |
| 04260463843637 | K171947 | 000 |
| 04260463843620 | K171947 | 000 |
| 04260463840919 | K171947 | 000 |