FDA.reportPublic FDA data

Steth IO

Primary DI
00860135001903
Brand
Steth IO
Company
Steth IO
Model
iPhone 6
Device description
Steth IO - The Smartphone Stethoscope for iPhone 6
Published
2018-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K160016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160016000Steth IOStratoscientific, Inc.2016-07-15DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860135001903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860135001903008601350019038601350019030860135001903

GMDN Terms#

Term, Definition table
TermDefinition
Electronic stethoscopeAn external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. It will typically be connected to a computer so that the results can be presented on a screen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079694124
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860135001958Steth IO Spot1.02022-07-21
00860135001910Steth IOiPhone 7/82018-04-09
00860135001927Steth IOiPhone 7+/8+2018-04-09
00860135001934Steth IOiPhone X2018-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 Devices, Inc.DQD2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Devices, Inc.DQD2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceEko Devices, Inc.DQD2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceEko Devices, Inc.DQD2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGEko Devices, Inc.DQD2026-04-03
00860011561736Stethophone ProSparrow Acoustics Inc.DQD2026-02-18
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Devices, Inc.DQD2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Devices, Inc.DQD2026-01-29
08809427311032SkeeperSmartsound CorportationDQD2026-01-12
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceEko Devices, Inc.DQD2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceEko Devices, Inc.DQD2025-11-07
06429811134003Keikku Digital StethoscopeLapsi Health Holding B.V.DQD2025-10-16
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceEko Devices, Inc.DQD2025-10-15
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryEko Devices, Inc.DQD2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteEko Devices, Inc.DQD2025-10-15
00850010298726CORE 500 Digital Stethoscope - Electric Pink ChestpieceEko Devices, Inc.DQD2025-08-12
00850010298757CORE 500 Digital Stethoscope - Electric Pink EarpieceEko Devices, Inc.DQD2025-08-12
00850010298788CORE 500 Digital Stethoscope - Bundle-SLVEko Devices, Inc.DQD2025-08-12
00850010298795CORE 500 Digital Stethoscope - Bundle-BLKEko Devices, Inc.DQD2025-08-12
00850010298801CORE 500 Digital Stethoscope - Bundle-CHPEko Devices, Inc.DQD2025-08-12
00850010298818CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club PinkEko Devices, Inc.DQD2025-08-12
00850010298733CORE 500 Digital Stethoscope - Ruby Earpiece Eko Devices, Inc.DQD2025-03-19
00850010298245CORE 500 Digital Stethoscope FIGS Earpiece - BlackEko Devices, Inc.DQD2025-03-18
00850010298252CORE 500 Digital Stethoscope FIGS Earpiece - GreyEko Devices, Inc.DQD2025-03-18
00850010298269CORE 500 Digital Stethoscope FIGS Earpiece - MauveEko Devices, Inc.DQD2025-03-18