← FDA Medical Device Classifications
Intra-Abdominal Pressure Monitoring Device
PHU · Unclassified · Unknown
Classification
- FDA Product Code
PHU
- Device class
- Unclassified
- Regulation
- —
- Review panel
- SU
- Medical specialty
- Unknown
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 12
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown