Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

System, Gastrointestinal Motility (electrical)

Diversatek Healthcare

The following data is part of a premarket notification filed by Diversatek Healthcare with the FDA for Diversatek Healthcare High Resolution Impedance Manometry (hrim) Probe.

Pre-market Notification Details

Device IDK190208
510k NumberK190208
Device Name:Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
ClassificationSystem, Gastrointestinal Motility (electrical)
Applicant Diversatek Healthcare 9150 Commerce Center Circle Suite 500 Highlands Ranch,  CO  80129
ContactLaura L. Boll
CorrespondentLaura L. Boll
Diversatek Healthcare 9150 Commerce Center Circle Suite 500 Highlands Ranch,  CO  80129
Product CodeFFX  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-04
Decision Date2019-10-03

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