510(k) K122184
K122184 is an FDA 510(k) premarket notification submitted by Cardiac Designs, LLC for the device "ECG CHECK". The FDA issued a decision of Substantially Equivalent on Feb 14, 2013. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Cardiac Designs, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 14, 2013
- Date Received
- Jul 23, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type
- 510(k)