K240057
- 510(k) number
- K240057
- Device name
- TraumaGuard Intra-abdominal Pressure Sensing System
- Applicant
- Sentinel Medical Technologies, LLC FL · US
- Product code
- EZL — Catheter, Retention Type, Balloon
- Decision date
- 2024-04-17
- Date received
- 2024-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240057.pdf
Official FDA record: K240057
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.