NONDISPOSABLE STIMULATING INSTRUMENTS

Stimulator, Nerve

NEUROVISION MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Neurovision Medical Products, Inc. with the FDA for Nondisposable Stimulating Instruments.

Pre-market Notification Details

Device IDK121931
510k NumberK121931
Device Name:NONDISPOSABLE STIMULATING INSTRUMENTS
ClassificationStimulator, Nerve
Applicant NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE, SUITE 1000 Ventura,  CA  93003
ContactChristine Vergely
CorrespondentChristine Vergely
NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE, SUITE 1000 Ventura,  CA  93003
Product CodeETN  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-02
Decision Date2012-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B066IJCBFB60 K121931 000
B006IJRF714BGL0 K121931 000
B006IJRF714B0 K121931 000
B006IHRN6210 K121931 000
B006IHRN6120 K121931 000
B006IHRN6020 K121931 000
B006IHR6200 K121931 000
B006T61075D0 K121931 000
B006ICSI0 K121931 000
B006IATF714BL0 K121931 000
B006IJRF714BL0 K121931 000
B006IKRF614B0 K121931 000
B006IKRF614BG0 K121931 000
B006ISHEMP0 K121931 000
B006ISHEMML0 K121931 000
B006ISHEMM0 K121931 000
B006ISHEMGM0 K121931 000
B006IPEG6120 K121931 000
B006IMF512BG0 K121931 000
B006IMF512B0 K121931 000
B006IMCF512BG0 K121931 000
B006IMCF512B0 K121931 000
B006IATF714B0 K121931 000

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