HEART SENTINEL
Detector And Alarm, Arrhythmia
TOTEMITE MEDICAL ELECTRONICS
The following data is part of a premarket notification filed by Totemite Medical Electronics with the FDA for Heart Sentinel.
Pre-market Notification Details
| Device ID | K802900 |
| 510k Number | K802900 |
| Device Name: | HEART SENTINEL |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | TOTEMITE MEDICAL ELECTRONICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-17 |
| Decision Date | 1981-03-11 |
Trademark Results [HEART SENTINEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEART SENTINEL 87070614 5257591 Live/Registered |
Parachute-app srl semplificata 2016-06-14 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.