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FDA 510(k), K123766, NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
FDA 510(k), K123766, NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
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510(K) Number: K123766
Device Name: NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
Manufacturer: LOIS KOTKOSKIE, PH. D
Device Classification Name: Syringe, Piston
Regulation Number: FMF
Classification Product Code: 12/07/2012
Date Received: 08/15/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
Manufacturer: LOIS KOTKOSKIE, PH. D
Device Classification Name: Syringe, Piston
Regulation Number: FMF
Classification Product Code: 12/07/2012
Date Received: 08/15/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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