Search Results
Found 1 results
510(k) Data Aggregation
K Number
K020365Device Name
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBEManufacturer
Date Cleared
2002-05-03
(88 days)
Product Code
Regulation Number
870.4200Type
TraditionalPanel
Cardiovascular (CV)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium.
Device Description
Not Found
AI/ML Overview
This document does not contain information about acceptance criteria, device performance, a study, or details about AI/ML models. It is a 510(k) clearance letter for a medical device (3T Disposable Myocardial Needle Temperature Probe) that indicates the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. Therefore, I cannot populate the requested table and information.
Ask a Question
Ask a specific question about this device
Page 1 of 1