CardioBand ECG Event Recorder— 510(k) K181998
Substantially EquivalentSamsung Strategy and Innovation Center (Ssic)
FDA 510(k) clearance K181998 for CardioBand ECG Event Recorder, Substantially Equivalent on 2018-11-15. Applicant: Samsung Strategy and Innovation Center (Ssic). Device class: 2.
Clearance details
- Applicant
- Samsung Strategy and Innovation Center (Ssic)
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code DPS
view allAdverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.