IONOMETER EF AND ACCESSORIES

Electrode, Ion Specific, Sodium

SMASH ENT., INC.

The following data is part of a premarket notification filed by Smash Ent., Inc. with the FDA for Ionometer Ef And Accessories.

Pre-market Notification Details

Device IDK870183
510k NumberK870183
Device Name:IONOMETER EF AND ACCESSORIES
ClassificationElectrode, Ion Specific, Sodium
Applicant SMASH ENT., INC. 5871 OXFORD ST. Shoreview,  MN  55125
ContactSteven V Bush
CorrespondentSteven V Bush
SMASH ENT., INC. 5871 OXFORD ST. Shoreview,  MN  55125
Product CodeJGS  
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-16
Decision Date1987-05-12

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