Not in use

GUDID 07290016672046

TYTO CARE LTD

Electronic stethoscope

• Primary Device ID: 07290016672046
• NIH Device Record Key: 924c6255-cde4-459e-8c92-5fab6161f261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Not in use
• Version Model Number: Not in use
• Company DUNS: 649125325
• Company Name: TYTO CARE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016672046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160401

FDA Product Code

• DQD: Stethoscope, Electronic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-08
• Device Publish Date: 2016-12-22

Devices Manufactured by TYTO CARE LTD

• 07290016672756 - TytoPro: 2024-06-03 TytoPro used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 0729001667278
• 07290016672763 - TytoHome: 2024-06-03 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166727
• 07290016672886 - Tyto Insights for Wheeze Detection: 2024-06-03 The “Tyto Insights for Wheeze Detection” is an over-the-counter artificial intelligence (AI) enabled decision support softwa
• 07290016672725 - Tyto Insights for Wheeze Detection: 2023-05-22 The Insights for Wheeze Detection is an over-the-counter decision support software system used in the evaluation of lung sounds
• 17290016672685 - TytoHome: 2022-05-19 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166724
• 07290016672473 - Tyto Device: 2020-12-17 The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation comp
• 17290016672487 - TytoHome: 2020-12-17 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166724
• 17290016672531 - Tyto Device: 2020-12-17 The Tyto Device G2 unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation co