The following data is part of a premarket notification filed by Etiometry, Inc. with the FDA for T3 Platform Software.
| Device ID | K202306 |
| 510k Number | K202306 |
| Device Name: | T3 Platform Software |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| 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 | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-14 |
| Decision Date | 2020-11-25 |