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FDA 510(k), K010031, NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
FDA 510(k), K010031, NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
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510(K) Number: K010031
Device Name: NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
Manufacturer: WAYNE K BARLOW
Device Classification Name: Device, Iontophoresis, Specific Uses
Regulation Number: KTB
Classification Product Code: 01/03/2001
Date Received: 03/20/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
Manufacturer: WAYNE K BARLOW
Device Classification Name: Device, Iontophoresis, Specific Uses
Regulation Number: KTB
Classification Product Code: 01/03/2001
Date Received: 03/20/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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