FDA.reportPublic FDA data

Stethophone Pro

Primary DI
00860011561736
Brand
Stethophone Pro
Company
Sparrow Acoustics Inc.
Model
3.8.x and newer
Device description
Smartphone-based digital stethoscope application for iPhone with OTC access to recording and core features, and prescription (Rx)-only access to AI-generated analysis results
Published
2026-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
DQDStethoscope, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQDStethoscope, ElectronicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252595000Stethophone ProSparrow Acoustics, Inc.2025-09-12DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011561736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011561736008600115617368600115617360860011561736

GMDN Terms#

Term, Definition table
TermDefinition
Electronic acoustic stethoscopeAn external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
201872068
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011561729Stethophone Pro3.x.x2025-01-13
00860011561705Stethophone2.x.x2024-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973660370001MinttiSuzhou Melodicare Medical Technology Co., Ltd.DQD2026-10-10
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DQD2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DQD2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DQD2026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackEko Health, Inc.DQD2026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryEko Health, Inc.DQD2026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetEko Health, Inc.DQD2026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificEko Health, Inc.DQD2026-10-01
00810209880255CORE 300™ Digital Stethoscope - CloudEko Health, Inc.DQD2026-10-01
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-06-22
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DQD2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DQD2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DQD2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DQD2026-06-12
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DQD2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DQD2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-05-18
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Health, Inc.DQD2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Health, Inc.DQD2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceEko Health, Inc.DQD2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceEko Health, Inc.DQD2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGEko Health, Inc.DQD2026-04-03
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Health, Inc.DQD2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Health, Inc.DQD2026-01-29
08809427311032SkeeperSmartsound CorportationDQD2026-01-12
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceEko Health, Inc.DQD2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceEko Health, Inc.DQD2025-11-07