T3 Platform software
FDA 510(k) clearance K213423 · decided 2023-01-06
Clearance details
- K-number
- K213423
- Device name
- T3 Platform software
- Applicant
- Etiometry, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-20
- Decision date
- 2023-01-06
- Days to decision
- 443 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AITRICS-VC (K240756) | Aitrics Co., Ltd. | 2024-07-23 |
| NAVOYCDS (K240558) | Algodx AB | 2024-07-22 |
| SpassageQ (K230386) | Spass, Inc. | 2023-06-15 |
| Biovitals Analytics Engine (K183282) | Biofourmis Singapore Pte., Ltd. | 2019-08-15 |
| T3 Software (K152258) | Etiometry, Inc. | 2016-03-31 |
| Personalized Physiology Analytics Engine software (K142512) | Vgbio, Inc (Dba Physiq) | 2015-06-11 |
| TRAUMA CARE EVALUATION (K843905) | Quantitative | 1985-09-26 |
Recalls involving this device
No recalls on record reference this clearance.