ACCU-SPHYG

System, Measurement, Blood-pressure, Non-invasive

OLYMPIC MEDICAL CORP.

The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Accu-sphyg.

Pre-market Notification Details

Device IDK832060
510k NumberK832060
Device Name:ACCU-SPHYG
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant OLYMPIC MEDICAL 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 Received1983-06-27
Decision Date1983-10-19

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