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…
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.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Tyto Stethoscope | Listed by | Tyto Care, Ltd., Israel |
| FDA product code | DQD |
| Device type | Stethoscope, Electronic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1875 |
| Record published | 2020-10-10 |
| Record revised | 2024-11-25 (version 9) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.