FDA 510(k), K133829, AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
FDA 510(k), K133829, AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
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510(K) Number: K133829
Device Name: AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
Manufacturer: ANDREAS HESSBERGER
Device Classification Name: Subsystem, Water Purification
Regulation Number: FIP
Classification Product Code: 12/17/2013
Date Received: 04/22/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
Manufacturer: ANDREAS HESSBERGER
Device Classification Name: Subsystem, Water Purification
Regulation Number: FIP
Classification Product Code: 12/17/2013
Date Received: 04/22/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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