The following data is part of a premarket notification filed by Waismed Ltd with the FDA for Nio-i.
| Device ID | K190538 |
| 510k Number | K190538 |
| Device Name: | NIO-I |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WaisMed Ltd 10 Amal St Afeck Industrial Park Rosh Haayin, IL 4809234 |
| Contact | Maya Shuvi |
| Correspondent | Tali Hazan Talmed Ltd Ramot Naftali, IL 1383000 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290008325066 | K190538 | 000 |