510(k) K151013
K151013 is an FDA 510(k) premarket notification submitted by Vitasystems GmbH for the device "Vitaphone Tele ECG Loop Recorder". The FDA issued a decision of Substantially Equivalent on April 30, 2015. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Vitasystems GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2015
- Date Received
- April 15, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type