MINICLINIC TM

Analyzer, Pacemaker Generator Function

INSTROMEDIX, INC.

The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Miniclinic Tm.

Pre-market Notification Details

Device IDK771922
510k NumberK771922
Device Name:MINICLINIC TM
ClassificationAnalyzer, Pacemaker Generator Function
Applicant INSTROMEDIX, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTC  
CFR Regulation Number870.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-10-13
Decision Date1977-11-02

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