The following data is part of a premarket notification filed by Clinical Innovations, Inc. with the FDA for Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-rectal Pressure Catheter, Model Gia-8500.
| Device ID | K022023 |
| 510k Number | K022023 |
| Device Name: | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | CLINICAL INNOVATIONS, INC. 747 WEST 4170 SOUTH Murray, UT 84123 |
| Contact | William Dean Wallace |
| Correspondent | William Dean Wallace CLINICAL INNOVATIONS, INC. 747 WEST 4170 SOUTH Murray, UT 84123 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-20 |
| Decision Date | 2003-01-07 |
| Summary: | summary |