The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Intra-abdominal Pressure Monitoring Device, Model Iap-001.
| Device ID | K070201 |
| 510k Number | K070201 |
| Device Name: | BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 |
| Classification | Intra-abdominal Pressure Monitoring Device |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Michelle Gudith |
| Correspondent | Michelle Gudith C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | PHU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-08-01 |
| Summary: | summary |