FDA.report

IMPEDIMED, INC.

Matched from indexed company URL: ImpediMed Limited

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30056999423005699942IMPEDIMED, INC.1Y2026-01-015900 Pasteur Ct Ste 125 Carlsbad CA US 92008

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
B277222LDEXU4002L-Dex® U400 - BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and dete+61738603700xx@xx.xx
B277223SFB72Imp SFB7 - BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and dete+61738603700xx@xx.xx
B27727269950SOZO Body Fluid Analyzer - SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor.+61738603700enquiries@impedimed.com
B27728269951SOZO Body Fluid Analyzer - SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. (Repackaged for use in Clinical evaluations (Trials))+61738603700enquiries@impedimed.com
B277SFT0250MYSOZO.com - Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.+61070386003700TSU@impedimed.com
B277SOZOAPP0SOZOapplication - Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.+61070386003700TSU@impedimed.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
665891395870155K232089SOZO ProDSB2023-10-17
665891764356201K230531SOZO ProQJB2023-05-04
665891613913790K230530SOZO ProOBH2023-05-04

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DSB12023-10-17
OBH12023-05-04
QJB12023-05-04

PMN

SOZO

2021-04-19

ImpediMed Limited

SOZO

2019-11-25

ImpediMed Limited

SOZO

2018-04-16

ImpediMed Limited

SOZO

2017-12-22

ImpediMed Limited

SOZO

2017-08-11

ImpediMed Limited

GUDID

SOZOapplication - Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.

IMPEDIMED LIMITED

2019-08-01