The following data is part of a premarket notification filed by Ivwatch, Llc with the FDA for Ivwatch Model 400, Device Accessories: Extension Module, Smarttouch Sensor, Patient Cable.
| Device ID | K192385 |
| 510k Number | K192385 |
| Device Name: | IvWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable |
| Classification | Peripheral Intravenous (piv) Infiltration Monitor |
| Applicant | ivWatch, LLC 630 Hofstadter Road, Suite 300 Newport News, VA 23606 |
| Contact | Holly Novak |
| Correspondent | Holly Novak ivWatch, LLC 630 Hofstadter Road, Suite 300 Newport News, VA 23606 |
| Product Code | PMS |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2020-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814088020591 | K192385 | 000 |
| 00814088020122 | K192385 | 000 |
| 00814088020115 | K192385 | 000 |