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 |