510(k) K070201
K070201 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001". The FDA issued a decision of Substantially Equivalent on August 1, 2007. The device falls under product code PHU (Intra-Abdominal Pressure Monitoring Device), a Class U device. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2007
- Date Received
- January 22, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intra-Abdominal Pressure Monitoring Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.