IvWatch
Peripheral Intravenous (piv) Infiltration Monitor
IvWatch, LLC
The following data is part of a premarket notification filed by Ivwatch, Llc with the FDA for Ivwatch.
Pre-market Notification Details
| Device ID | K162478 |
| 510k Number | K162478 |
| Device Name: | IvWatch |
| Classification | Peripheral Intravenous (piv) Infiltration Monitor |
| Applicant | ivWatch, LLC 1100 Exploration Way, Suite 209 Hampton, VA 23666 |
| Contact | Jaclyn Lautz |
| Correspondent | Jaclyn Lautz ivWatch, LLC 1100 Exploration Way, Suite 209 Hampton, VA 23666 |
| Product Code | PMS |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-06 |
| Decision Date | 2016-12-22 |
| Summary: | summary |
Trademark Results [IvWatch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IVWATCH 87287880 5218641 Live/Registered |
ivWatch, LLC 2017-01-03 |
 IVWATCH 77674830 3788391 Dead/Cancelled |
IVWATCH, LLC 2009-02-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.