Class Class II
Eyer Retinal Camera NM-STD (K221329)
Description
Eyer Retinal Camera NM-STD by Phelcom Technologies, an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221329
Clearance Date2023-02-22
Clearance TypeTraditional
Product CodeHKI
Regulation Number886.1120
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221329
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. Eyer Retinal Camera NM-STD (K221329) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora... | Optomed OY | 2018 |
Trace the full predicate network for K221329
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.