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FDA 510(k), K130338, IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
FDA 510(k), K130338, IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
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510(K) Number: K130338
Device Name: IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
Manufacturer: John j Smith, M.D., J.D.
Device Classification Name: Monitor, Extracellular Fluid, Lymphedema, Extremity
Regulation Number: OBH
Classification Product Code: 02/11/2013
Date Received: 05/31/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
Manufacturer: John j Smith, M.D., J.D.
Device Classification Name: Monitor, Extracellular Fluid, Lymphedema, Extremity
Regulation Number: OBH
Classification Product Code: 02/11/2013
Date Received: 05/31/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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