The following data is part of a premarket notification filed by National Custom Ent., Inc. with the FDA for Marquette Eagle Monitor Model 4000, Model N3024.
| Device ID | K012263 |
| 510k Number | K012263 |
| Device Name: | MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 |
| Classification | Electrocardiograph |
| Applicant | NATIONAL CUSTOM ENT., INC. 1133 EAST CLIFF RD. Burnsville, MN 55337 |
| Contact | Don Pelletier |
| Correspondent | Don Pelletier NATIONAL CUSTOM ENT., INC. 1133 EAST CLIFF RD. Burnsville, MN 55337 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-18 |
| Decision Date | 2001-10-10 |