510(k) DEN180021
- Device
- Early Bird Bleed Monitoring System
- Applicant
- Saranas, Inc.
- 510(k) number
- DEN180021
- Product code
- QFJ
- Decision
- Unknown (DENG)
- Decision date
- 2019-03-01
- Date received
- 2018-04-23
- Regulation
- 870.1345
- Classification name
- Intravascular Bleed Monitor
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zaffer Syed
- Address
- 2450 Holcombe Blvd., Suite X Houston TX US 77021 77021
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QFJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230273 | Saranas Early Bird Bleed Monitoring System | Saranas, Inc. | 2023-05-25 |