ROTEM sigma Thromboelastometry System
FDA 510(k) clearance K201440 · decided 2022-07-08
Clearance details
- K-number
- K201440
- Device name
- ROTEM sigma Thromboelastometry System
- Applicant
- Tem Innovations GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-06-01
- Decision date
- 2022-07-08
- Days to decision
- 767 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.