510(k) K230273
- Device
- Saranas Early Bird Bleed Monitoring System
- Applicant
- Saranas, Inc.
- 510(k) number
- K230273
- Product code
- QFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-25
- Date received
- 2023-01-31
- Regulation
- 870.1345
- Classification name
- Intravascular Bleed Monitor
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Odell Roberts
- Address
- 2450 Holcombe Blvd., Suite X Houston TX US 77021 77021
Source Documents#
Other 510(k) Records For Product Code QFJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN180021 | Early Bird Bleed Monitoring System | Saranas, Inc. | 2019-03-01 |