Insulin Pump Secondary Display

Device Code: 665

Product Code(s): PKU

Definition: The Purpose Of The Insulin Pump Secondary Display Is To Notify Another Person Of The Patient's Insulin Pump Usage Information In Real Time. The Secondary Display Is Intended For Providing Secondary Notification Of Insulin Pump Usage And Does Not Repl

Device Classification Information

• Device Type ID: 665
• Device Name: Insulin Pump Secondary Display
• Physical State: Typically A Software Device Installed On A Third-party Mobile Device, Or Implemented In A Web-based Platform.
• Technical Method: Receives And Displays Real-time Patient Data From An Insulin Pump.
• Target Area: N/a
• Regulation Description: Continuous Glucose Monitor Secondary Display.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1350 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: PKU
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 665
• Device: Insulin Pump Secondary Display
• Product Code: PKU
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Continuous Glucose Monitor Secondary Display.
• CFR Regulation Number: 862.1350 [🔎]

TPLC Last Update: 2019-04-02 19:38:20