Medline Singe Patient Use Blood Pressure Cuff

Blood Pressure Cuff

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Singe Patient Use Blood Pressure Cuff.

Pre-market Notification Details

Device IDK161035
510k NumberK161035
Device Name:Medline Singe Patient Use Blood Pressure Cuff
ClassificationBlood Pressure Cuff
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-13
Decision Date2016-06-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884389976071 K161035 000

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