The following data is part of a premarket notification filed by Medtronic Functional Diagnostics A/s with the FDA for Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models 9043g0121-9043g0151, 9043s0101.
| Device ID | K992713 |
| 510k Number | K992713 |
| Device Name: | POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 |
| 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 | 1999-08-12 |
| Decision Date | 1999-11-10 |
| Summary: | summary |