The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Simpliscriptor Ek 31/101 037 16.
| Device ID | K832184 |
| 510k Number | K832184 |
| Device Name: | SIMPLISCRIPTOR EK 31/101 037 16 |
| Classification | Electrocardiograph |
| Applicant | LITTON MEDICAL ELECTRONICS 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 | 1983-07-06 |
| Decision Date | 1983-10-31 |