T3 Software
FDA 510(k) clearance K152258 · decided 2016-03-31
Clearance details
- K-number
- K152258
- Device name
- T3 Software
- Applicant
- Etiometry, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-11
- Decision date
- 2016-03-31
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- PLB
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| AITRICS-VC (K240756) | Aitrics Co., Ltd. | 2024-07-23 |
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| TRAUMA CARE EVALUATION (K843905) | Quantitative | 1985-09-26 |
Recalls involving this device
No recalls on record reference this clearance.