FDA.reportPublic FDA data

Stethee Pro Mobile iOS Application

Primary DI
09351356000048
Brand
Stethee Pro Mobile iOS Application
Company
M3DICINE PTY LTD
Model
2.0.X
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.
Published
2020-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
DQCPhonocardiograph
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
DQCPhonocardiographCardiovascular1
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193631000Stethee Pro 1, Stethee Pro Software SystemM3Dicine Pty , Ltd.2020-10-09DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351356000048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351356000048093513560000489351356000048

GMDN Terms#

Term, Definition table
TermDefinition
PhonocardiographA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
757852710
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351356000017Stethee Pro12020-04-23
09351356000031Stethee Pro Mobile Android Application2.0.X2020-12-23
09351356000055Stethee Pro Central Web Application 2.0.X2020-12-23

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