510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NTUClass II

Evoked Potential Stimulator, Thermal

21 CFR 882.1870 / Neurology
FDA source (opens on fda.gov)

NTU is the FDA product code for Evoked Potential Stimulator, Thermal, a class II device type, regulated under 21 CFR 882.1870. FDA's definition for this code reads: "Intended to evaluate the functionality of human pain reception and transmission of sensory pathways". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NTU
Device name
Evoked Potential Stimulator, Thermal
FDA definition
Intended to evaluate the functionality of human pain reception and transmission of sensory pathways
Regulation
21 CFR 882.1870
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code NTU

By decision year
3 clearances under product code NTU with a decision year between 2005 and 2006, 2005 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NTU by decision year
YearClearances
20052
20061

Applicants with the most clearances

Product code NTU
Applicants holding the most 510(k) clearances under product code NTU
ApplicantClearances
Medoc Ltd. Advanced Medical Systems3

Companies listing this code with FDA

Companies whose registered establishments list this code