510(k) K162478
- Device
- IvWatch
- Applicant
- IvWatch, LLC
- 510(k) number
- K162478
- Product code
- PMS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-22
- Date received
- 2016-09-06
- Regulation
- 880.5725
- Classification name
- Peripheral Intravenous (piv) Infiltration Monitor
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jaclyn Lautz
- Address
- 1100 Exploration Way, Suite 209 Hampton VA US 23666 23666
FDA Registration Numbers#
- 3011490091
- 1064858
Source Documents#
Other 510(k) Records For Product Code PMS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233881 | ivWatch® Model 400 | Ivwatch, LLC | 2024-03-15 |
| K222212 | ivWatch Model 400 | Ivwatch, LLC | 2022-08-24 |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | Ivwatch, LLC | 2020-07-02 |
| K153605 | ivWatch Model 400 | Ivwatch, LLC | 2016-02-11 |
Legacy Summary#
summary
FDA Review#
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