The following data is part of a De Novo classification by Saranas, Inc. with the FDA for Early Bird Bleed Monitoring System.
| DeNovo ID | DEN180021 |
| Device Name: | Early Bird Bleed Monitoring System |
| Applicant | Saranas, Inc. 2450 Holcombe Blvd. Suite X Houston, TX 77021 |
| Contact | Zaffer Syed |
| Product Code | QFJ |
| Decision | Granted (DENG) |
| Review Advisory Board | Cardiovascular |
| Type | Direct |
| Date Received | 2018-04-23 |
| Decision Date | 2019-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866532000402 | DEN180021 | 000 |
| 00866532000419 | DEN180021 | 000 |