PHV — Continuous Glucose Monitor Retrospective Data Analysis Software Class I
FDA product code PHV covers "Continuous Glucose Monitor Retrospective Data Analysis Software", a Class I medical device regulated under 21 CFR 862.2120. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PHV
- Device Class
- Class I
- Regulation Number
- 862.2120
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN140016 | dexcom | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE | August 19, 2014 |