The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for Obstetrical Doppler.
| Device ID | K841805 |
| 510k Number | K841805 |
| Device Name: | OBSTETRICAL DOPPLER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | EPCOM MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-01 |
| Decision Date | 1984-06-19 |