K162478 is an FDA 510(k) clearance for the ivWatch. This device is classified as a Peripheral Intravenous (piv) Infiltration Monitor (Class II - Special Controls, product code PMS).
Submitted by Ivwatch, LLC (Hampton, US). The FDA issued a Cleared decision on December 22, 2016, 107 days after receiving the submission on September 6, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725. Peripheral Catheter Monitor (piv) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations..
| 510(k) Number | K162478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2016 |
| Decision Date | December 22, 2016 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PMS - Peripheral Intravenous (piv) Infiltration Monitor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | Peripheral Catheter Monitor (piv) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations. |