K233881
- 510(k) number
- K233881
- Device name
- ivWatch® Model 400
- Applicant
- Ivwatch, LLC VA · US
- Product code
- PMS — Peripheral Intravenous (Piv) Infiltration Monitor
- Decision date
- 2024-03-15
- Date received
- 2023-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K233881.pdf
Official FDA record: K233881
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.