FDA product code HMK: Euthyscope, Ac-Powered
HMK is the FDA product code for euthyscope, ac-powered. It is a Class II device, regulated under 21 CFR 886.1250 and reviewed by the Ophthalmic panel. Devices under HMK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Euthyscope, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.1250 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HMK devices
openFDA lists no recalls for product code HMK.
Frequently asked questions
What is FDA product code HMK?
HMK is the FDA product code for euthyscope, ac-powered. It is a Class II device, regulated under 21 CFR 886.1250 and reviewed by the Ophthalmic panel.
What device class is HMK?
Class II, regulation 21 CFR 886.1250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HMK
- Run a recall and safety report across every HMK manufacturer
- Watch product code HMK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.