Digitimer DS7AP Constant Current Stimulator

Stimulator, Muscle, Powered

Digitimer Ltd.

The following data is part of a premarket notification filed by Digitimer Ltd. with the FDA for Digitimer Ds7ap Constant Current Stimulator.

Pre-market Notification Details

Device IDK172381
510k NumberK172381
Device Name:Digitimer DS7AP Constant Current Stimulator
ClassificationStimulator, Muscle, Powered
Applicant Digitimer Ltd. 37 Hydeway Welwyn Garden City,  GB
ContactJohn Smale
CorrespondentJohn Smale
Digitimer Ltd. 37 Hydeway Welwyn Garden City,  GB
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-07
Decision Date2018-03-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060490360058 K172381 000

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