510(k) K170506
K170506 is an FDA 510(k) premarket notification submitted by Cardiac Designs, Inc. for the device "ECG Check - Universal, ECG Check - Universal Plus". The FDA issued a decision of Substantially Equivalent on Oct 2, 2017. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Cardiac Designs, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 2, 2017
- Date Received
- Feb 21, 2017
- 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)