Tray, Start/stop (including Contents), Dialysis

Device Code: 1898

Product Code(s): FKG

Device Classification Information

• Device Type ID: 1898
• Device Name: Tray, Start/stop (including Contents), Dialysis
• Regulation Description: Hemodialysis System And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Renal Devices Branch (RNDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 876.5820 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FKG
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 9-89 ISO 8638 Third Edition 2010-07-01
  Cadiovascular Implants And Extracorporeal Blood Circuit For Hemodialyzers, Hemodialfilters, And Hemofilters

Total Product Life Cycle

• Device Type ID: 1898
• Device: Tray, Start/stop (including Contents), Dialysis
• Product Code: FKG
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Hemodialysis System And Accessories.
• CFR Regulation Number: 876.5820 [🔎]

TPLC Last Update: 2019-04-02 20:01:37