3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE— 510(k) K020365

Name: FDA 510(k) clearance K020365
Creator: U.S. Food and Drug Administration
Published: 2002-05-03

Substantially Equivalent

3t Medical Systems, LLC

FDA 510(k) clearance K020365 for 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE, Substantially Equivalent on 2002-05-03. Applicant: 3t Medical Systems, LLC. Device class: 1.

Clearance details

Applicant: 3t Medical Systems, LLC
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 2002-02-04
Decision date: 2002-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conifer, CO, US

Download summary PDF View on FDA.gov ↗

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