The following data is part of a premarket notification filed by Medtronic Functional Diagnostics A/s with the FDA for Polygram 98 Anorectal Function Testing Application, Model 9043s0111.
| Device ID | K000386 |
| 510k Number | K000386 |
| Device Name: | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740 |
| Contact | Tove Kjaer |
| Correspondent | Tove Kjaer 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 | 2000-02-07 |
| Decision Date | 2000-05-05 |