Product code PHV— Clinical Chemistry
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
- Classification name
- Continuous Glucose Monitor Retrospective Data Analysis Software
- Device class
- Class 1
- Regulation
- 21 CFR 862.2120
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.”
Market context for product code PHV
FDA has cleared device under product code PHV, all in 2014, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code PHV
Adverse events under product code PHV
product code PHV- Malfunction
- 1,984
- Total
- 1,984
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PHV
Data sourced from openFDA. This site is unofficial and independent of the FDA.