Tyto Insights for Wheeze Detection

Primary DI
07290016672725
Brand
Tyto Insights for Wheeze Detection
Company
TYTO CARE LTD
Model
Tyto Insights for Wheeze Detection _US
Device description
The Insights for Wheeze Detection is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.
Published
2023-05-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
PHZAbnormal Breath Sound Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHZAbnormal Breath Sound DeviceAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221614000TytoCare Lung Sounds AnalyzerTyto Care , Ltd.2023-02-24PHZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016672725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016672725072900166727257290016672725

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 is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649125325
Device count
1

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
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
07290016672190Tyto StethoscopeTyto Stethoscope800-000082019-01-24
07290016672213TytoHomeTytoHome900-000152019-01-24
17290016672685TytoHomeTytoHome G2 US900-00015-0632022-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290020123008Tyto Insights for Crackles DetectionTYTO CARE LTDPHZ2024-12-23
07290016672886Tyto Insights for Wheeze DetectionTYTO CARE LTDPHZ2024-05-26