The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Mini Pecg-modification.
| Device ID | K841148 |
| 510k Number | K841148 |
| Device Name: | MINI PECG-MODIFICATION |
| Classification | Electrocardiograph |
| Applicant | INTERSECT SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-21 |
| Decision Date | 1984-04-17 |