ClearanceBrief
Company ยท KR

Huvitz Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2023. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
HJOBiomicroscope, Slit-Lamp, Ac-Powered2
NFJSystem, Image Management, Ophthalmic2
HKICamera, Ophthalmic, Ac-Powered1
HKYTonometer, Manual1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 23, 2023K232143Applanation Tonometer HT-5000
Huvitz Co., Ltd., KR
HKY
Feb 2, 2021K202097Fundus Camera
Huvitz Co., Ltd., KR
HKI
Jul 18, 2019K191615Huvitz Imaging System
Huvitz Co., Ltd., KR
NFJ
Apr 6, 2017K161829Huvitz Imaging System
Huvitz Co., Ltd., KR
NFJ
Dec 3, 2009K093639SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
Huvitz Co., Ltd.
HJO
Jan 11, 2008K073190SLIT LAMP
Huvitz Co., Ltd.
HJO

Latest recalls

DateFirm and productCodeLinked 510(k)
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