The following data is part of a premarket notification filed by Einstein Works Llc with the FDA for Nio-i.
| Device ID | K211395 |
| 510k Number | K211395 |
| Device Name: | NIO-I |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Einstein Works LLC 5312 Elm St Houston, TX 77081 |
| Contact | Roy Bachrach |
| Correspondent | Roy Bachrach Einstein Works LLC 5312 Elm St Houston, TX 77081 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-05 |
| Decision Date | 2021-07-28 |