DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH

Stimulator, Electrical, Evoked Response

DIGITIMER LTD.

The following data is part of a premarket notification filed by Digitimer Ltd. with the FDA for Ds7a Constant Current High Voltage Stimulator, Model Ds7a; Ds7ah Constant Current High Voltage Stimulator, Model Ds7ah.

Pre-market Notification Details

Device IDK051357
510k NumberK051357
Device Name:DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
ClassificationStimulator, Electrical, Evoked Response
Applicant DIGITIMER LTD. ONE EAST BROWARD BOULEVARD SUITE 700 Fort Lauderdale,  FL  33301
ContactHarry J Benedict
CorrespondentHarry J Benedict
DIGITIMER LTD. ONE EAST BROWARD BOULEVARD SUITE 700 Fort Lauderdale,  FL  33301
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-24
Decision Date2005-09-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060490360010 K051357 000
05060490360003 K051357 000

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