Stethee Pro Mobile iOS Application

FDA UDI

Class I (US FDA UDI)

by M3Dicine Pty , Ltd.

Identity

Trade Name: Stethee Pro Mobile iOS Application FDA UDI
Generic Name: Phonocardiograph FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 2.0.X FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 09351356000048 FDA UDI
510(k) Number: K193631 FDA UDI
FDA Product Code: DQC FDA UDI
DRG FDA UDI
BZQ FDA UDI
GMDN Term: Phonocardiograph FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.2390 FDA UDI
870.2910 FDA UDI
868.2375 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Phonocardiograph Stethoscope application software

Stethee Pro Mobile iOS Application by M3Dicine Pty , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stethoscope application software.

ClearSteth — GlobalMed Holdings, LLC · Class II
3M™ Littmann® — 3M COMPANY · Class I
Littmann® Telesteth™ — 3M COMPANY · Class II
Stethee Pro Mobile Android Application — M3Dicine Pty , Ltd. · Class I
Stethee Pro Central Web Application — M3Dicine Pty , Ltd. · Class I

Cleared under the same submission

K193631 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: M3Dicine Pty , Ltd.

Sources (1)

FDA UDI 6e24a754-e1cc-4886-aafd-b433cfd7b332 34 fields · synced May 30, 2026