BLOOD PRESSURE DEVICE, 400 SERIES

System, Measurement, Blood-pressure, Non-invasive

MED-TEK CORP.

The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for Blood Pressure Device, 400 Series.

Pre-market Notification Details

Device IDK781906
510k NumberK781906
Device Name:BLOOD PRESSURE DEVICE, 400 SERIES
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant MED-TEK CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-11-13
Decision Date1978-11-16

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