SweatC

GUDID B322A0011

SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.

LD TECHNOLOGY, LLC

Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter
Primary Device IDB322A0011
NIH Device Record Keycc769e94-7643-42e3-99d7-f9c728f238b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSweatC
Version Model NumberA001
Company DUNS079443785
Company NameLD TECHNOLOGY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB322A0011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZODevice, Galvanic Skin Response Measurement

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-07
Device Publish Date2019-03-12

Devices Manufactured by LD TECHNOLOGY, LLC

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B322G0011 - ANS1 Software2024-03-13 "ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with data
B322H0011 - LD-EKG2024-03-13 "LD EKG is intended for use: The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical acti
B322B0011 - TM-Oxi System2019-11-08 The T- Oxi device indicated for use in non- The vital signs monitor is a portable device invasively measuring and displaying fun
B322C0011 - TBL-ABI2019-11-08 The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is
B322A0011 - SweatC2019-06-07SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
B322A0011 - SweatC2019-06-07 SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
B322D0011 - LD-Oxy2019-02-18 To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoel

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