The following data is part of a premarket notification filed by Remco Italia S.p.a. with the FDA for Elan Digital 12 Channel Electrocardiograph.
| Device ID | K032200 |
| 510k Number | K032200 |
| Device Name: | ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | REMCO ITALIA S.P.A. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm REMCO ITALIA S.P.A. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-18 |
| Decision Date | 2003-10-03 |
| Summary: | summary |