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Tyto Device

TYTO CARE LTD · Model Tyto Device G2 Plastic Gray, US · UDI-DI 07290016672534

KYT FLL

510(k) clearances

Adverse events

Recalls

161

Facilities

Description

The Tyto Device G2 unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto Otoscope. As a spare part the Tyto Device is provided with catalog number 900-00050 and DI 17290016672531. Intended use for Tyto Exam Camera: The Tyto Camera is an electronic camera that enables capturing and transmission of video and still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at one location on an IP network can view images and videos 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. Intended use for Tyto Thermometer: The Tyto Thermometer is a clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead as the measurement site on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments

Recalls

Date	Firm	Reason
2023-03-20	DermLite LLC	Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.