The following data is part of a premarket notification filed by Medtronic Functional Diagnostics A/s with the FDA for Polygram Net Electrogastrography Application Software, Model 9043s0151; Polygraf Id, Model 9043g0102.
| Device ID | K014269 |
| 510k Number | K014269 |
| Device Name: | POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 |
| Classification | System, Electrogastrography (egg) |
| 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 | MYE |
| CFR Regulation Number | 876.1735 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-27 |
| Decision Date | 2002-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101363330 | K014269 | 000 |