Neurometrix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
DEN210046Quell-FMMay 18, 2022
K152954QuellJanuary 5, 2016
K140586ASCEND ELECTRODENovember 17, 2014
K140333ASCENDJuly 3, 2014
K130919SENSUSJuly 2, 2013
K121816SENSUS ELECTRODENovember 26, 2012
K121184SENSUSAugust 2, 2012
K091155ASCENDSeptember 3, 2009
K083322NEUROMETRIX BIOAMPLIFIERMay 27, 2009
K083818UNIVERSAL ELECTRODESJanuary 21, 2009
K081871UNIVERSAL ELECTRODESSeptember 29, 2008
K070109NEUROMETRIX ADVANCEApril 25, 2008
K060584NC-STATJuly 31, 2006
K041320MODIFICATION TO NC-STATAugust 12, 2004
K013459MODIFICATION OF NC-STATJanuary 17, 2002
K003508NC-STATJanuary 17, 2001
K000565MODIFICATION TO NC-STATJune 27, 2000
K982359NC-STATOctober 2, 1998