WANDY DISPERSVIE ELECTRODE

Electrosurgical Patient Return Electrode

BIO-MED USA INC.

The following data is part of a premarket notification filed by Bio-med Usa Inc. with the FDA for Wandy Dispersvie Electrode.

Pre-market Notification Details

Device IDK121268
510k NumberK121268
Device Name:WANDY DISPERSVIE ELECTRODE
ClassificationElectrosurgical Patient Return Electrode
Applicant BIO-MED USA INC. 111 ELLISON STREET Paterson,  NJ  07505
ContactYoung Chi
CorrespondentYoung Chi
BIO-MED USA INC. 111 ELLISON STREET Paterson,  NJ  07505
Product CodeODR  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-26
Decision Date2012-12-20
Summary:summary

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