Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
Device Code: 685
Product Code(s):
QDL Definition: An Integrated Continuous Glucose Monitoring System For Professional Retrospective Use Is A Continuous Glucose Recording Device Indicated For The Retrospective Discovery, Analysis, And Interpretation Of Glycemic Variability In Persons Age 2 And Older
Device Classification Information
| Device Type ID | 685 |
| Device Name | Integrated Continuous Glucose Monitoring System For Professional Retrospective Use |
| Physical State | Sensor, Transmitter, Receiver |
| Technical Method | Devices Stores Data To Be Used Later By A Healthcare Practitioner Regarding Measured Glucose. |
| Target Area | Human Tissue |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1355 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDL |
| 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 | 685 |
| Device | Integrated Continuous Glucose Monitoring System For Professional Retrospective Use |
| Product Code | QDL |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1355 [🔎] |
TPLC Last Update: 2019-04-02 19:38:40