PHU — Intra-Abdominal Pressure Monitoring Device Class U
FDA product code PHU covers "Intra-Abdominal Pressure Monitoring Device", a Class U medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PHU
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.