510(k) K060911
K060911 is an FDA 510(k) premarket notification submitted by Card Guard Scientific Survival , Ltd. for the device "CG-6108 ARRHYTHMIA ECG EVENT RECORDER". The FDA issued a decision of Substantially Equivalent on August 22, 2006. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Card Guard Scientific Survival , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2006
- Date Received
- April 3, 2006
- Clearance Type
- Special
- 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