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FDA 510(k), K133807, MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
FDA 510(k), K133807, MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
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510(K) Number: K133807
Device Name: MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
Manufacturer: GAMBRO RENAL PRODUCTS, INC.
Device Classification Name: apparatus, hemoperfusion, sorbent
Regulation Number: 876.5870
Classification Product Code: FLD
Date Received: 12/16/2013
Decision Date: 03/26/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
Manufacturer: GAMBRO RENAL PRODUCTS, INC.
Device Classification Name: apparatus, hemoperfusion, sorbent
Regulation Number: 876.5870
Classification Product Code: FLD
Date Received: 12/16/2013
Decision Date: 03/26/2014
Regulation Medical Specialty: Gastroenterology/Urology
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- Delivery: Approximately 1 to 2 weeks
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