← 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
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