DPM CALCULATOR

Calculator/data Processing Module, For Clinical Use

ISO-DATA, INC.

The following data is part of a premarket notification filed by Iso-data, Inc. with the FDA for Dpm Calculator.

Pre-market Notification Details

Device IDK810631
510k NumberK810631
Device Name:DPM CALCULATOR
ClassificationCalculator/data Processing Module, For Clinical Use
Applicant ISO-DATA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJQP  
CFR Regulation Number862.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-10
Decision Date1981-03-27

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