SmartHDM-510 System

Meter, Conductivity, Non-remote

Mesa Laboratories, Inc.

The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Smarthdm-510 System.

Pre-market Notification Details

Device IDK201765
510k NumberK201765
Device Name:SmartHDM-510 System
ClassificationMeter, Conductivity, Non-remote
Applicant Mesa Laboratories, Inc. 12100 West 6th Ave. Lakewood,  CO  80228
ContactJamie Louie
CorrespondentJohannes Pfingstmann
IBP Medical GmbH Ikarusallee 15 Hannover,  DE 30179
Product CodeFIZ  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-09-02

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