FDA.reportPublic FDA data

Tyto Stethoscope

Primary DI
07290016672190
Brand
Tyto Stethoscope
Company
TYTO CARE LTD
Model
Tyto Stethoscope
Catalog number
800-00008
Device description
The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Published
2019-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQDStethoscope, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQDStethoscope, ElectronicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181612000Tyto Stethoscope (OTC)Tyto Care , Ltd.2018-12-17DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016672190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016672190072900166721907290016672190

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

Contacts#

Phone, Email table
PhoneEmail
+972722210750stellar@tytocare.com
+972722210750amirh@tytocare.com

Regulatory Flags#

DUNS number
649125325
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290020123008Tyto Insights for Crackles DetectionTyto Insights for Crackles Detection2024-12-23
07290016672305TytoHomeTytoHome US900-00015-0062019-09-03
07290016672428TytoHomeTytoHome US900-00015-0092020-10-10
07290016672480TytoHomeTytoHome G2 US900-00015-0042020-12-09
07290016672688TytoHomeTytoHome G2 US900-00015-0632022-05-11
07290016672756TytoProTytoPro G2 900-00002-0622024-05-26
07290016672763TytoHomeTytoHome G2 US900-00015-0642024-05-26
07290016672886Tyto Insights for Wheeze DetectionTyto Insights for Wheeze Detection _US2024-05-26
07290016672725Tyto Insights for Wheeze DetectionTyto Insights for Wheeze Detection _US2023-05-14
07290016672541TytoProTytoPro G2 US900-00002-0072020-12-09
07290016672404Tyto StethoscopeTyto Stethoscope, Plastic, black, US800-000272020-10-10
07290016672299TytoProTytoPro US900-00002-0052019-09-03
07290016672343Tyto StethoscopeTyto Stethoscope, Zamak, BLK, US800-000192019-09-03
07290016672374Tyto StethoscopeTyto Stethoscope, Zamak, Gray, US800-000232019-09-03
07290016672015Tyto StethoscopeTyto Stethoscope800-000012016-12-22
07290016672039TytoProTytoPro900-000022016-12-22
07290016672046Not in useNot in use2016-12-22
07290016672053TytoHomeTytoHome900-000152018-01-04
07290016672213TytoHomeTytoHome900-000152019-01-24
17290016672685TytoHomeTytoHome G2 US900-00015-0632022-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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