510(k) K043380
K043380 is an FDA 510(k) premarket notification submitted by Monebo Technologies, Inc. for the device "MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1". The FDA issued a decision of Substantially Equivalent on Apr 26, 2005. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Monebo Technologies, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 26, 2005
- Date Received
- Dec 8, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type
- 510(k)