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510(k) K150657

Device
Phoenix XL Dialysate Meter
Applicant
Mesa Laboratories, Inc.
510(k) number
K150657
Product code
FIZ  
Decision
Substantially Equivalent (SESE)
Decision date
2015-09-21
Date received
2015-03-13
Regulation
876.5820
Classification name
Meter, Conductivity, Non-remote
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jamie Louie
Address
12100 W. 6th Ave. Lakewood CO US 80228 80228

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FIZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201765SmartHDM-510 SystemMesa Laboratories, Inc.2020-09-02
K05081290XL INSTRUMENTATION SYSTEMMesa Laboratories, Inc.2005-05-05
K020908HDM97Ibp Instruments GmbH2002-05-22
K020909HDM99Ibp Instruments GmbH2002-05-22
K992431NEO-2 METERAutomata Instrumentation, Inc.1999-10-13
K981294ODYSSEY INSTRUMENTATION SYSTEMAutomata Instrumentation, Inc.1998-07-08
K955298PHOENIX DIALYSATE METERAutomata Medical Instrumentation, Inc.1996-02-29
K920810NEO-STAT DIALYSATE METERAutomata Medical Instrumentation, Inc.1993-01-15
K881098MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METERAutomata, Inc.1988-04-21
K871708NEO-I TEMPERATURE & CONDUCTIVITY METERAutomata, Inc.1987-06-17
K853735COLORADO MEDICAL MODEL CTM-3000Colorado Medical, Inc.1985-10-04
K780932MODEL 80 CONDUCTIVITY/TEMP.TEST UNITWestern Laboratories Corp.1978-08-31

Legacy Summary#

summary

FDA Review#

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