AUTOMATED PHYSIOLOGIC PROFILE MONITOR

Computer, Diagnostic, Pre-programmed, Single-function

LIFE SCIENCES MANUFACTURING, INC.

The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Automated Physiologic Profile Monitor.

Pre-market Notification Details

Device IDK811560
510k NumberK811560
Device Name:AUTOMATED PHYSIOLOGIC PROFILE MONITOR
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant LIFE SCIENCES MANUFACTURING, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-02
Decision Date1981-06-18

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