The following data is part of a premarket notification filed by Medtronic Functional Diagnostics A/s with the FDA for Anorectal Manometry Suite, Model 9032s0201.
| Device ID | K991389 |
| 510k Number | K991389 |
| Device Name: | ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TONSBAKKEN 16-18 SKOVLUNDE Copenhagen, DK Dk-2740 |
| Contact | Ann-christine Jonsson |
| Correspondent | Ann-christine Jonsson MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TONSBAKKEN 16-18 SKOVLUNDE Copenhagen, 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 | 1999-04-21 |
| Decision Date | 1999-07-15 |
| Summary: | summary |