SD-900 OSCILLOMETRIC BP MONITOR

System, Measurement, Blood-pressure, Non-invasive

INDUSTRIAL & BIOMEDICAL SENSORS CORP.

The following data is part of a premarket notification filed by Industrial & Biomedical Sensors Corp. with the FDA for Sd-900 Oscillometric Bp Monitor.

Pre-market Notification Details

Device IDK802218
510k NumberK802218
Device Name:SD-900 OSCILLOMETRIC BP MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant INDUSTRIAL & BIOMEDICAL SENSORS 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 Received1980-09-12
Decision Date1980-10-23

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