Early Bird Bleed Monitoring System
FDA 510(k) clearance DEN180021 · decided 2019-03-01
Clearance details
- K-number
- DEN180021
- Device name
- Early Bird Bleed Monitoring System
- Applicant
- Saranas, Inc.
- Decision
- Unknown
- Date received
- 2018-04-23
- Decision date
- 2019-03-01
- Days to decision
- 312 days
- Clearance type
- Direct
- Product code
- QFJ
- Device class
- 2
- Regulation number
- 870.1345
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Saranas Early Bird Bleed Monitoring System (K230273) | Saranas, Inc. | 2023-05-25 |
Recalls involving this device
No recalls on record reference this clearance.