The following data is part of a premarket notification filed by Medical Equipment Devices, Inc. with the FDA for Heart-alert.
| Device ID | K820444 |
| 510k Number | K820444 |
| Device Name: | HEART-ALERT |
| Classification | Platform, Force-measuring |
| Applicant | MEDICAL EQUIPMENT DEVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHX |
| CFR Regulation Number | 890.1575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-18 |
| Decision Date | 1982-03-12 |