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HKM — Retinoscope, Battery-Powered Class I

FDA Device Classification

Classification Details

Product Code
HKM
Device Class
Class I
Regulation Number
886.1780
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964338rudolf riester gmbh and co. kgRI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOTJanuary 9, 1997
K950794neitz instruments companySTREAK RETINOSCOPE RX-RCMarch 28, 1995
K950795neitz instruments companySTREAK RETINOSCOPE RX-RPMarch 28, 1995
K950792neitz instruments companySTREAK RETINOSCOPE RX-3AMarch 28, 1995
K950791neitz instruments companySTREAK RETINOSCOPE RX-3March 28, 1995
K950793neitz instruments companySPOT RETINOSCOPE RX-3SPMarch 28, 1995
K840840electro optical instrumentsGENERATED RETINAL REFLEX IMAGERY SYSJuly 12, 1984