Stethee Pro Mobile iOS Application

Basic Information

• Brand Name: Stethee Pro Mobile iOS Application
• Primary DI: 09351356000048
• Version / Model: 2.0.X
• Company Name: M3DICINE PTY LTD
• Labeler DUNS: 757852710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-23
• Public Version: 1
• Public Version Date: 2020-12-31
• Public Version Status: New
• Public Device Record Key: 6e24a754-e1cc-4886-aafd-b433cfd7b332

Device Description

Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQC	Phonocardiograph	Cardiovascular	870.2390	1
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13017	Phonocardiograph	A device for recording heart sounds at the body surface through the heart's actions which cause vibrations that are transmitted through organs and tissue to the body surface. These are detected by microphones, processed in an electroacoustic transducer, and give sound characteristics in a phonocardiogram. This is used to assess the low frequency sounds (atrial and ventricular gallops), and high frequency sounds (mitral regurgitation and ventricular septal defect). Some also record subsonic frequencies (a few Hertz) considered as vibrations, typically recorded by an apexcardiograph. This method may also be integrated in other electrocardiograph (ECG) devices.	No	Active
41177	Stethoscope application software	A data application program designed for use in, or together with, a computer, e.g., a standard personal computer (PC), and an electronic stethoscope. This software program will permit, e.g., the visualization of the sound picture which can be used for enhanced diagnostic purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09351356000048	GS1

Premarket Submissions

Submission Number	Supplement Number
K193631	000