MULTIDAY, MODELS 8300 AND 8310

Electrode, Cutaneous

MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Multiday, Models 8300 And 8310.

Pre-market Notification Details

Device IDK882888
510k NumberK882888
Device Name:MULTIDAY, MODELS 8300 AND 8310
ClassificationElectrode, Cutaneous
Applicant MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul,  MN  55112
ContactBruce Macfarlane,phd
CorrespondentBruce Macfarlane,phd
MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul,  MN  55112
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-11
Decision Date1988-09-30

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