TytoCare

TYTO CARE LTD · Model TytoCare · UDI-DI 07290016672008

510(k) clearances

Adverse events

Recalls

Facilities

Description

The TytoCare unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto Ottoscope 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 Basal Thermometer: The Tyto Basal Thermometer is an electronic thermometer that enables measuring basal body temperature as an aid in ovulation prediction to aid in conception (not to be used for contraception). In addition, the thermometer enables storage and transmitting the temperature measurement to a clinician on site or at a different location on the IP network with the signal carried on an IP connection between the two locations.

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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.