The following data is part of a premarket notification filed by Ivwatch, Llc with the FDA for Ivwatch Model 400.
| Device ID | K142374 |
| 510k Number | K142374 |
| Device Name: | IvWatch Model 400 |
| Classification | Accessories, Pump, Infusion |
| Applicant | ivWatch, LLC 469 McLaws Circle Williamsburg, VA 23185 |
| Contact | Javier Garriz |
| Correspondent | Javier Garriz ivWatch, LLC 469 McLaws Circle Williamsburg, VA 23185 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-26 |
| Decision Date | 2015-02-13 |
| Summary: | summary |