K190538 is an FDA 510(k) clearance for the NIO-I. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Waismed, Ltd. (Rosh Haayin, IL). The FDA issued a Cleared decision on October 7, 2019, 217 days after receiving the submission on March 4, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K190538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2019 |
| Decision Date | October 07, 2019 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |