The following data is part of a premarket notification filed by Ivwatch, Llc with the FDA for Ivwatch Model 400.
| Device ID | K222212 |
| 510k Number | K222212 |
| Device Name: | IvWatch Model 400 |
| Classification | Peripheral Intravenous (piv) Infiltration Monitor |
| Applicant | ivWatch, LLC 700 Tech Center Parkway, Suite 300 Newport News, VA 23606 |
| Contact | Holly Novak |
| Correspondent | Holly Novak ivWatch, LLC 700 Tech Center Parkway, Suite 300 Newport News, VA 23606 |
| Product Code | PMS |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-08-24 |