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FDA 510(k), K043380, MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
FDA 510(k), K043380, MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
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510(K) Number: K043380
Device Name: MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
Manufacturer: MONEBO TECHNOLOGIES, INC.
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 12/08/2004
Decision Date: 04/26/2005
Regulation Medical Specialty: Cardiovascular
Device Name: MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
Manufacturer: MONEBO TECHNOLOGIES, INC.
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 12/08/2004
Decision Date: 04/26/2005
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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