The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Polygram Net Biofeedback Application.
| Device ID | K041244 |
| 510k Number | K041244 |
| Device Name: | POLYGRAM NET BIOFEEDBACK APPLICATION |
| Classification | Device, Biofeedback |
| Applicant | MEDTRONIC VASCULAR 4000 LEXINGTON AVE., NORTH Shoreview, MN 55126 -2893 |
| Contact | Julie Goode |
| Correspondent | Julie Goode MEDTRONIC VASCULAR 4000 LEXINGTON AVE., NORTH Shoreview, MN 55126 -2893 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-11 |
| Decision Date | 2004-08-12 |
| Summary: | summary |