INFRASONDE D4000 ELECTRONIC B-P MONITOR

System, Measurement, Blood-pressure, Non-invasive

SPHYGMETRICS, INC.

The following data is part of a premarket notification filed by Sphygmetrics, Inc. with the FDA for Infrasonde D4000 Electronic B-p Monitor.

Pre-market Notification Details

Device IDK800401
510k NumberK800401
Device Name:INFRASONDE D4000 ELECTRONIC B-P MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant SPHYGMETRICS, INC. 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 Received1980-02-26
Decision Date1980-03-12

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