Phoenix XL Dialysate Meter

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 Phoenix Xl Dialysate Meter.

Pre-market Notification Details

Device IDK150657
510k NumberK150657
Device Name:Phoenix XL Dialysate Meter
ClassificationMeter, Conductivity, Non-remote
Applicant Mesa Laboratories, Inc. 12100 West 6th Avenue Lakewood,  CO  80228
ContactJamie Louie
CorrespondentJamie Louie
Mesa Laboratories, Inc. 12100 West 6th Avenue Lakewood,  CO  80228
Product CodeFIZ  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-13
Decision Date2015-09-21
Summary:summary

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