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

Stimulator, Low Electric Field, Tumor Treatment

Unknown
FDA source (opens on fda.gov)

NZK is the FDA product code for Stimulator, Low Electric Field, Tumor Treatment, a class III device type. FDA's definition for this code reads: "Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NZK
Device name
Stimulator, Low Electric Field, Tumor Treatment
FDA definition
Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code