K070201 is an FDA 510(k) clearance for the BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001. This device is classified as a Intra-abdominal Pressure Monitoring Device.
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on August 1, 2007, 191 days after receiving the submission on January 22, 2007.
This device falls under the General & Plastic Surgery FDA review panel. Abdominal Intracompartmental Pressure Monitoring Using Bladder Pressure As A Surrogate For Abdominal Pressure..
| 510(k) Number | K070201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2007 |
| Decision Date | August 01, 2007 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PHU — Intra-abdominal Pressure Monitoring Device |
| Device Class | — |
| Definition | Abdominal Intracompartmental Pressure Monitoring Using Bladder Pressure As A Surrogate For Abdominal Pressure. |