Etiometry Platform— 510(k) K254066
Substantially EquivalentEtiometry, Inc.
FDA 510(k) clearance K254066 for Etiometry Platform, Substantially Equivalent on 2026-04-03. Applicant: Etiometry, Inc.. Device class: 2.
Clearance details
- Applicant
- Etiometry, Inc.
- Product code
- Code PPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dedham, MA, US
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