The following data is part of a premarket notification filed by Medtronic Functional Diagnostics A/s with the FDA for Digitrapper Delta, Model 9043g0201 And Polygram '98 Ph Extension Model 9043s0111.
| Device ID | K981733 |
| 510k Number | K981733 |
| Device Name: | DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740 |
| Contact | Ann-christine Jonsson |
| Correspondent | Ann-christine Jonsson MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1999-02-04 |
| Summary: | summary |