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FDA 510(k), K061828, LORENZ BIOTECH APTIVA, VERSION 2.13
FDA 510(k), K061828, LORENZ BIOTECH APTIVA, VERSION 2.13
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510(K) Number: K061828
Device Name: LORENZ BIOTECH APTIVA, VERSION 2.13
Manufacturer: LORENZ BIOTECH S.P.A.
Device Classification Name: stimulator, nerve, transcutaneous, for pain relief
Regulation Number: 882.5890
Classification Product Code: GZJ
Date Received: 06/28/2006
Decision Date: 08/24/2007
Regulation Medical Specialty: Neurology
Device Name: LORENZ BIOTECH APTIVA, VERSION 2.13
Manufacturer: LORENZ BIOTECH S.P.A.
Device Classification Name: stimulator, nerve, transcutaneous, for pain relief
Regulation Number: 882.5890
Classification Product Code: GZJ
Date Received: 06/28/2006
Decision Date: 08/24/2007
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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