Medical Device Manufacturer · US , Flintville , TN

Huvitz Co., Ltd.

6 submissions · 6 cleared · Since 2008
6
Total
6
Cleared
0
Denied

Huvitz Co., Ltd. — FDA 510(k) Submissions

Huvitz Co., Ltd. has submitted 6 FDA 510(k) premarket notifications since 2008, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Biomicroscope, Slit-lamp, Ac-powered, System, Image Management, Ophthalmic, Camera, Ophthalmic, Ac-powered, Tonometer, Manual . Use the specialty filter in the sidebar to narrow results.

6 devices
1–6 of 6
Applanation Tonometer HT-5000
K232143 · HKY Tonometer, Manual · Ophthalmic
Oct 2023 96d
Fundus Camera
K202097 · HKI Camera, Ophthalmic,... · Ophthalmic
Feb 2021 188d
Huvitz Imaging System
K191615 · NFJ System, Image Management,... · Ophthalmic
Jul 2019 30d
Huvitz Imaging System
K161829 · NFJ System, Image Management,... · Ophthalmic
Apr 2017 275d
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
K093639 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Dec 2009 9d
SLIT LAMP
K073190 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Jan 2008 59d
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