GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT

Stimulator, Muscle, Powered

SELECTIVEMED COMPONENTS INC.

The following data is part of a premarket notification filed by Selectivemed Components Inc. with the FDA for Guardian Dysphagia Dual Channel Nmes Unit.

Pre-market Notification Details

Device IDK120922
510k NumberK120922
Device Name:GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
ClassificationStimulator, Muscle, Powered
Applicant SELECTIVEMED COMPONENTS INC. 8870 RAVELLO CT Naples,  FL  34114
ContactDaniel Kamm
CorrespondentDaniel Kamm
SELECTIVEMED COMPONENTS INC. 8870 RAVELLO CT Naples,  FL  34114
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-27
Decision Date2013-02-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B736465731 K120922 000

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