The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Model Ap 180 Mini-monitor.
| Device ID | K812256 |
| 510k Number | K812256 |
| Device Name: | MODEL AP 180 MINI-MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | SONICAID, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-12 |
| Decision Date | 1981-10-20 |