The following data is part of a premarket notification filed by Ivwatch, Llc with the FDA for Ivwatch Model 400.
| Device ID | K153605 |
| 510k Number | K153605 |
| Device Name: | IvWatch Model 400 |
| Classification | Peripheral Intravenous (piv) Infiltration Monitor |
| Applicant | ivWatch, LLC 469 McLaws Circle Williamsburg, VA 23185 |
| Contact | Jaclyn Lautz |
| Correspondent | Jaclyn Lautz ivWatch, LLC 469 McLaws Circle Williamsburg, VA 23185 |
| Product Code | PMS |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-17 |
| Decision Date | 2016-02-11 |
| Summary: | summary |