Pump, Infusion, Gallstone Dissolution

Device Code: 2679

Product Code(s): MHD

Device Classification Information

• Device Type ID: 2679
• Device Name: Pump, Infusion, Gallstone Dissolution
• Regulation Description: Infusion Pump.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5725 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MHD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 6-273 ISO 23908 First Edition 2011-06-11
  Sharps Injury Protection - Requirements And Test Methods - Sharps Protection Features For Single-use Hypodermic Needles, Introducers For Catheters And Needles Used For Blood Sampling

Total Product Life Cycle

• Device Type ID: 2679
• Device: Pump, Infusion, Gallstone Dissolution
• Product Code: MHD
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Infusion Pump.
• CFR Regulation Number: 880.5725 [🔎]

TPLC Last Update: 2019-04-02 20:17:18