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

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• Primary Device ID: 09351356000017
• NIH Device Record Key: 9d7d735a-c137-4846-b9a9-f2638b5e90b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stethee Pro
• Version Model Number: 1
• Company DUNS: 757852710
• Company Name: M3DICINE PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351356000017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172296

FDA Product Code

• DQD: Stethoscope, Electronic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-04-23

Devices Manufactured by M3DICINE PTY LTD

• 09351356000031 - Stethee Pro Mobile Android Application: 2020-12-31 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 Application: 2020-12-31 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 Pro: 2020-05-06The 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 Pro: 2020-05-06 The Stethee™ Pro 1 is an electronic stethoscope intended for medical diagnostic purposes only. It may be used for the detecti