The following data is part of a premarket notification filed by Hmba with the FDA for Heart Monitor Bracelet Alarm.
| Device ID | K822316 |
| 510k Number | K822316 |
| Device Name: | HEART MONITOR BRACELET ALARM |
| Classification | Monitor, Line Isolation |
| Applicant | HMBA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRI |
| CFR Regulation Number | 870.2620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-03 |
| Decision Date | 1982-09-21 |