FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T3 Software
K Number: K163065
·
Decision May 26, 2017
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
11
Review Days
205
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Basic Information
- Device Name
- T3 Software
- K Number
- K163065
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Etiometry, Inc.
- Date Received
- November 2, 2016
- Decision Date
- May 26, 2017
- Product Code
- MWI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Etiometry, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254066 | Etiometry Platform | Apr 3, 2026 | Substantially Equivalent |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Feb 12, 2025 | Substantially Equivalent |
| K223578 | T3 Platform software | Jul 7, 2023 | Substantially Equivalent |
| K213423 | T3 Platform software | Jan 6, 2023 | Substantially Equivalent |
| K213230 | T3 Platform Software | Jun 22, 2022 | Substantially Equivalent |
| K202306 | T3 Platform software | Nov 25, 2020 | Substantially Equivalent |
| K190273 | T3 Platform software | Dec 8, 2019 | Substantially Equivalent |
| K152258 | T3 Software | Mar 31, 2016 | Substantially Equivalent |
| K151715 | T3 Software | Oct 29, 2015 | Substantially Equivalent |
| K142732 | T3 Software | Mar 4, 2015 | Substantially Equivalent |