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510(k) Data Aggregation
K Number
K131711Device Name
YZ3 PORTABLE SLIT LAMP
Manufacturer
SUZHOU 66 VISION TECH CO., LTD.
Date Cleared
2014-05-09
(332 days)
Product Code
HJO
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU 66 VISION TECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The YZ3 Portable Slit Lamp is intended for use in the examination of the anterior segment of the eye.
Device Description
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K Number
K052599Device Name
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
Manufacturer
SUZHOU 66 VISION TECH CO., LTD.
Date Cleared
2006-11-07
(412 days)
Product Code
HLJ
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU 66 VISION TECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.
Device Description
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