Tetra (TM-20); Tetra (TM-50)— 510(k) K251105

Name: FDA 510(k) clearance K251105
Creator: U.S. Food and Drug Administration
Published: 2025-12-22

Substantially Equivalent

Emed Technologies Corporation

FDA 510(k) clearance K251105 for Tetra (TM-20); Tetra (TM-50), Substantially Equivalent on 2025-12-22. Applicant: Emed Technologies Corporation. Device class: 2.

Clearance details

Applicant: Emed Technologies Corporation
Product code: Code PKP
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2025-04-11
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

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