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FDA 510(k), K012988, HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
FDA 510(k), K012988, HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
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510(K) Number: K012988
Device Name: HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
Manufacturer: BAXTER HEALTHCARE CORP.
Device Classification Name: system, peritoneal, automatic delivery
Regulation Number: 876.5630
Classification Product Code: FKX
Date Received: 09/06/2001
Decision Date: 12/05/2001
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
Manufacturer: BAXTER HEALTHCARE CORP.
Device Classification Name: system, peritoneal, automatic delivery
Regulation Number: 876.5630
Classification Product Code: FKX
Date Received: 09/06/2001
Decision Date: 12/05/2001
Regulation Medical Specialty: Gastroenterology/Urology
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- Delivery: Approximately 1 to 2 weeks
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