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, Polygram 98 Esophageal Manometry Application, Polygraf Id.
| Device ID | K011472 |
| 510k Number | K011472 |
| Device Name: | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID |
| 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 | 2001-05-14 |
| Decision Date | 2001-08-10 |