510(k) K063044
K063044 is an FDA 510(k) premarket notification submitted by Monebo Technologies, Inc. for the device "CARDIOBELT ELECTRODE BELT". The FDA issued a decision of Substantially Equivalent on Mar 23, 2007. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Monebo Technologies, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 23, 2007
- Date Received
- Oct 4, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Electrode, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2360
- Review Panel
- CV
- Submission Type
- 510(k) Exempt