INTRACRANIAL PRESSURING MONITORING SYST.

Device, Monitoring, Intracranial Pressure

PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Intracranial Pressuring Monitoring Syst..

Pre-market Notification Details

Device IDK802100
510k NumberK802100
Device Name:INTRACRANIAL PRESSURING MONITORING SYST.
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-09-03
Decision Date1980-09-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000030261 K802100 000
00763000030148 K802100 000
00643169497078 K802100 000
00643169496910 K802100 000
00643169496842 K802100 000

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