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510(k) K950793

Device
SPOT RETINOSCOPE RX-3SP
Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
510(k) number
K950793
Product code
HKM  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-28
Date received
1995-02-21
Regulation
886.1780
Classification name
Retinoscope, Battery-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
YASUO KAWANO
Address
36-13, Wakamatsu-Cho, Shinjuku-Ku Tokyo JP 162-0056 162-0056

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HKM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964338RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOTRudolf Riester GmbH & Co. KG1997-01-09
K950791STREAK RETINOSCOPE RX-3Neitz Instruments Company, Ltd.1995-03-28
K950792STREAK RETINOSCOPE RX-3ANeitz Instruments Company, Ltd.1995-03-28
K950794STREAK RETINOSCOPE RX-RCNeitz Instruments Company, Ltd.1995-03-28
K950795STREAK RETINOSCOPE RX-RPNeitz Instruments Company, Ltd.1995-03-28
K840840GENERATED RETINAL REFLEX IMAGERY SYSElectro Optical Instruments1984-07-12

Legacy Summary#

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FDA Review#

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