T3 Platform software— 510(k) K213423
Substantially EquivalentEtiometry, Inc.
FDA 510(k) clearance K213423 for T3 Platform software, Substantially Equivalent on 2023-01-06. Applicant: Etiometry, Inc.. Device class: 2.
Clearance details
- Applicant
- Etiometry, Inc.
- Product code
- Code PLB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code PLB
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