FDA Product Code
FDA Product Code PMS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233881 | ivWatch® Model 400 | Ivwatch, LLC | 2024-03-15 | Traditional | PDF ↗ |
| K222212 | ivWatch Model 400 | Ivwatch, LLC | 2022-08-24 | Special | PDF ↗ |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | Ivwatch, LLC | 2020-07-02 | Traditional | PDF ↗ |
| K162478 | ivWatch | Ivwatch, LLC | 2016-12-22 | Traditional | PDF ↗ |
| K153605 | ivWatch Model 400 | Ivwatch, LLC | 2016-02-11 | Special | PDF ↗ |
Product code PMS · Class II · General Hospital. Data: openFDA.