Tristel Duo ULT
FDA 510(k) clearance DEN220041 · decided 2023-06-02
Clearance details
- K-number
- DEN220041
- Device name
- Tristel Duo ULT
- Applicant
- Tristel Solutions Limited
- Decision
- Unknown
- Date received
- 2022-06-29
- Decision date
- 2023-06-02
- Days to decision
- 338 days
- Clearance type
- Direct
- Product code
- QWS
- Device class
- 2
- Regulation number
- 880.6886
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Snailwell, GB
- 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 |
|---|---|---|
| Tristel OPH (K242732) | Tristel Solutions , Ltd. | 2025-05-09 |
Recalls involving this device
No recalls on record reference this clearance.