510(k) K181998
K181998 is an FDA 510(k) premarket notification submitted by Samsung Strategy And Innovation Center (Ssic) for the device "CardioBand ECG Event Recorder". The FDA issued a decision of Substantially Equivalent on Nov 15, 2018. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 15, 2018
- Date Received
- Jul 26, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type
- 510(k)