The following data is part of a premarket notification filed by Mediplus Ltd. with the FDA for Mediplus Single Use Gi Manometry Catheter.
| Device ID | K013704 |
| 510k Number | K013704 |
| Device Name: | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | MEDIPLUS LTD. 541 MORENO CIRCLE NE St. Petersburg, FL 33703 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul MEDIPLUS LTD. 541 MORENO CIRCLE NE St. Petersburg, FL 33703 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-08 |
| Decision Date | 2002-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15055140701111 | K013704 | 000 |
| 15055140700633 | K013704 | 000 |
| 15055140700534 | K013704 | 000 |
| 15055140700527 | K013704 | 000 |
| 15055140700510 | K013704 | 000 |
| 15055140700503 | K013704 | 000 |
| 15055140700497 | K013704 | 000 |