The following data is part of a premarket notification filed by Samsung Strategy And Innovation Center (ssic) with the FDA for Cardioband Ecg Event Recorder.
| Device ID | K181998 |
| 510k Number | K181998 |
| Device Name: | CardioBand ECG Event Recorder |
| Classification | Electrocardiograph |
| Applicant | Samsung Strategy And Innovation Center (SSIC) 3655 North First Street San Jose, CA 95134 |
| Contact | Bhupinder Singh |
| Correspondent | Matthew Wiggins SAMSUNG STRATEGY AND INNOVATION CENTER (SSIC) 3655 North First Street San Jose, CA 95134 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-26 |
| Decision Date | 2018-11-15 |
| Summary: | summary |