Stethee Pro

GUDID 09351356000017

The Stethee™ Pro 1 is an electronic stethoscope intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The Stethee™ Pro transfers sounds to the user via Bluetooth connected headphones. It also includes features that permit it to record and store sounds on a peripheral smart device using a Bluetooth connection. The smart device makes use of a downloaded companion stand-alone Mobile Medical Application (MMA), Stethee™ App to record, manage and replay the captured patient sounds on the smart device. Stethee™ App is also able to display the audio file as a phonocardiograph and calculate and display a simple heart rate.

M3DICINE PTY LTD

Electronic stethoscope
Primary Device ID09351356000017
NIH Device Record Key9d7d735a-c137-4846-b9a9-f2638b5e90b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameStethee Pro
Version Model Number1
Company DUNS757852710
Company NameM3DICINE PTY LTD
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109351356000017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQDStethoscope, Electronic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-06
Device Publish Date2020-04-23

Devices Manufactured by M3DICINE PTY LTD

09351356000031 - Stethee Pro Mobile Android Application2020-12-31 Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is in
09351356000048 - Stethee Pro Mobile iOS Application2020-12-31 Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intend
09351356000055 - Stethee Pro Central Web Application 2020-12-31 Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intend
09351356000017 - Stethee Pro2020-05-06The Stethee™ Pro 1 is an electronic stethoscope intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The Stethee™ Pro transfers sounds to the user via Bluetooth connected headphones. It also includes features that permit it to record and store sounds on a peripheral smart device using a Bluetooth connection. The smart device makes use of a downloaded companion stand-alone Mobile Medical Application (MMA), Stethee™ App to record, manage and replay the captured patient sounds on the smart device. Stethee™ App is also able to display the audio file as a phonocardiograph and calculate and display a simple heart rate.
09351356000017 - Stethee Pro2020-05-06 The Stethee™ Pro 1 is an electronic stethoscope intended for medical diagnostic purposes only. It may be used for the detecti
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