STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE— 510(k) DEN140016

Unknown

Dexcom, Inc.

FDA 510(k) clearance DEN140016 for STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE, Unknown on 2014-08-19. Applicant: Dexcom, Inc..

Clearance details

Applicant: Dexcom, Inc.
Product code: Code PHV
Advisory panel: Clinical Chemistry
Date received: 2014-04-22
Decision date: 2014-08-19
Decision: Unknown
Clearance type: Direct
Location: San Diego, CA, US

View on FDA.gov ↗

Adverse events under product code PHV

product code PHV

Malfunction: 1,984
Total: 1,984

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.