The following data is part of a premarket notification filed by Etiometry, Inc. with the FDA for T3 Platform Software.
| Device ID | K213230 |
| 510k Number | K213230 |
| Device Name: | T3 Platform Software |
| Classification | Adjunctive Cardiovascular Status Indicator |
| Applicant | Etiometry, Inc. 280 Summer St, 4th Floor Boston, MA 02210 |
| Contact | Tim Hanson |
| Correspondent | Tim Hanson Etiometry, Inc. 280 Summer St, 4th Floor Boston, MA 02210 |
| Product Code | PPW |
| Subsequent Product Code | MWI |
| Subsequent Product Code | PLB |
| CFR Regulation Number | 870.2200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-06-22 |