Class Class II
Medaica M1 Telehealth Stethoscope (K223166)
Description
Medaica M1 Telehealth Stethoscope by Medaica, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223166
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeDQD
Regulation Number870.1875
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223166
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Medaica M1 Telehealth Stethoscope (K223166) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181612 | Tyto Stethoscope (OTC) | Tyto Care , Ltd. | 2018 |
Trace the full predicate network for K223166
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.