510(k) K140847
K140847 is an FDA 510(k) premarket notification submitted by Labtech Kft. for the device "CARDIOSPY ECG HOLTER SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 5, 2014. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2014
- Date Received
- April 3, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type