FDA 510(k), K131897, CV3000 HOLTER ANALYSIS SYSTEM
FDA 510(k), K131897, CV3000 HOLTER ANALYSIS SYSTEM
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$149.00 USD
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510(K) Number: K131897
Device Name: CV3000 HOLTER ANALYSIS SYSTEM
Manufacturer:
Device Classification Name: Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation Number: 870.2800
Classification Product Code: MLO
Date Received: 06/25/2013
Decision Date: 11/26/2013
Regulation Medical Specialty: Cardiovascular
Device Name: CV3000 HOLTER ANALYSIS SYSTEM
Manufacturer:
Device Classification Name: Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation Number: 870.2800
Classification Product Code: MLO
Date Received: 06/25/2013
Decision Date: 11/26/2013
Regulation Medical Specialty: Cardiovascular