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Found 4 results
510(k) Data Aggregation
K Number
K013805Device Name
KOWA AUTOMATED TONOMETER KT-500
Manufacturer
KOWA OPTIMED, INC.
Date Cleared
2002-10-11
(330 days)
Product Code
HKX
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
KOWA OPTIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR THE MEASUREMENTS OF INTRAOCULAR PRESSURE TO AID IN THE DIAGNOSIS OF GLAUCOMA.
Device Description
Not Found
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K Number
K961090Device Name
AUTOMATIC VISUAL FIELD PLOTTER AP-125
Manufacturer
KOWA OPTIMED, INC.
Date Cleared
1996-06-17
(90 days)
Product Code
HPT
Regulation Number
886.1605Why did this record match?
Applicant Name (Manufacturer) :
KOWA OPTIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960924Device Name
KOWA HAND-HELD APPLANATION TONOMETER HA-1
Manufacturer
KOWA OPTIMED, INC.
Date Cleared
1996-06-04
(90 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
KOWA OPTIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955442Device Name
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
Manufacturer
KOWA OPTIMED, INC.
Date Cleared
1996-01-03
(36 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
KOWA OPTIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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