The following data is part of a De Novo classification by Dexcom, Inc. with the FDA for Studio On The Cloud Data Management Software.
| DeNovo ID | DEN140016 |
| Device Name: | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE |
| Classification | Continuous Glucose Monitor Retrospective Data Analysis Software |
| Applicant | DEXCOM, INC. 6340 Sequence Dr San Diego, CA 92121 |
| Contact | Andrew Balo |
| Product Code | PHV |
| CFR Regulation Number | 862.2120 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Clinical Chemistry |
| Classification Advisory | Clinical Chemistry |
| Type | Direct |
| Date Received | 2014-04-22 |
| Decision Date | 2014-08-19 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00038270000451 | DEN140016 | 000 |