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FDA 510(k), K123935, IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
FDA 510(k), K123935, IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
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$149.00 USD
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510(K) Number: K123935
Device Name: IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
Manufacturer: ANDON MEDICAL CO., LTD.
Device Classification Name: system, test, blood glucose, over the counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 12/20/2012
Decision Date: 04/12/2013
Regulation Medical Specialty: Clinical Chemistry
Device Name: IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
Manufacturer: ANDON MEDICAL CO., LTD.
Device Classification Name: system, test, blood glucose, over the counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 12/20/2012
Decision Date: 04/12/2013
Regulation Medical Specialty: Clinical Chemistry
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