510(k) K062397
K062397 is an FDA 510(k) premarket notification submitted by Del Mar Reynolds Medical, Ltd. for the device "SENTINEL". The FDA issued a decision of Substantially Equivalent on January 25, 2007. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Del Mar Reynolds Medical, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2007
- Date Received
- August 16, 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