The following data is part of a premarket notification filed by Mediplus Ltd. with the FDA for Mediplus Single Use Lower Gi Manometry Catheter.
| Device ID | K031617 |
| 510k Number | K031617 |
| Device Name: | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | MEDIPLUS LTD. 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin MEDIPLUS LTD. 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-23 |
| Decision Date | 2004-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15055140703863 | K031617 | 000 |
| 15055140702811 | K031617 | 000 |
| 15055140701104 | K031617 | 000 |
| 15055140700862 | K031617 | 000 |
| 15055140700855 | K031617 | 000 |
| 15055140700770 | K031617 | 000 |
| 15055140700763 | K031617 | 000 |
| 15055140700756 | K031617 | 000 |
| 15055140700589 | K031617 | 000 |