Data / Medical devices / United States / Etiometry Inc.
Etiometry Inc.: FDA-registered device maker in Dedham, MA, United States, 6 510(k) clearances
Etiometry Inc. is registered with the FDA (registration 3011683100) in Dedham, MA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 12, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011683100
- Address
- 770 Legacy Place Floor 2, Suite 34, Dedham, MA, United States, 02026
- Owner or operator
- Etiometry Inc. (10049448)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 1, 2020
- Registered through
- 2027
- Brand names listed
- EtioLink, Etiometry Platform, Etiometry Platform Software, T3 Platform software, The Etiometry Platform
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunctive Cardiovascular Status Indicator | PPW | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Multivariate Vital Signs Index | PLB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 12, 2025 | K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | PPW | Substantially Equivalent | Etiometry, Inc. | accessdata.fda.gov |
| July 7, 2023 | K223578 | T3 Platform software | PPW | Substantially Equivalent | Etiometry, Inc. | accessdata.fda.gov |
| January 6, 2023 | K213423 | T3 Platform software | PLB | Substantially Equivalent | Etiometry, Inc. | accessdata.fda.gov |
| June 22, 2022 | K213230 | T3 Platform Software | PPW | Substantially Equivalent | Etiometry, Inc. | accessdata.fda.gov |
| November 25, 2020 | K202306 | T3 Platform software | MWI | Substantially Equivalent | Etiometry, Inc. | accessdata.fda.gov |
| December 8, 2019 | K190273 | T3 Platform software | MWI | Substantially Equivalent | Etiometry, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Multivariate Vital Signs Index
- All makers of Adjunctive Cardiovascular Status Indicator
- All makers of Medical Device Data System
Updated February 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.