Class Class II
Stethophone (K240901)
Description
Stethophone by Sparrow Acoustics, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240901
Clearance Date2024-09-19
Clearance TypeTraditional
Product CodeDQD
Regulation Number870.1875
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240901
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. Stethophone (K240901) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023 |
| K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 |
Trace the full predicate network for K240901
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.