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FDA 510(k), K100066, DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
FDA 510(k), K100066, DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
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510(K) Number: K100066
Device Name: DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
Manufacturer: MALINDA PEEPLES
Device Classification Name: Accessories, Pump, Infusion
Regulation Number: MRZ
Classification Product Code: KXA
Date Received: 01/11/2010
Decision Date: 07/15/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
Manufacturer: MALINDA PEEPLES
Device Classification Name: Accessories, Pump, Infusion
Regulation Number: MRZ
Classification Product Code: KXA
Date Received: 01/11/2010
Decision Date: 07/15/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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