The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Fetal Heart Detector #d206.
| Device ID | K800859 |
| 510k Number | K800859 |
| Device Name: | FETAL HEART DETECTOR #D206 |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | SONICAID, 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 | 1980-04-15 |
| Decision Date | 1980-05-14 |