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HKM — Retinoscope, Battery-Powered Class I

FDA Device Classification

FDA product code HKM covers "Retinoscope, Battery-Powered", a Class I medical device regulated under 21 CFR 886.1780. Submissions are reviewed by the Ophthalmic panel. At least 7 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HKM
Device Class
Class I
Regulation Number
886.1780
Submission Type
510(k) Exempt
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-SPOTJan 9, 1997
K950794Neitz Instruments CompanySTREAK RETINOSCOPE RX-RCMar 28, 1995
K950791Neitz Instruments CompanySTREAK RETINOSCOPE RX-3Mar 28, 1995
K950792Neitz Instruments CompanySTREAK RETINOSCOPE RX-3AMar 28, 1995
K950793Neitz Instruments CompanySPOT RETINOSCOPE RX-3SPMar 28, 1995
K950795Neitz Instruments CompanySTREAK RETINOSCOPE RX-RPMar 28, 1995
K840840Electro Optical InstrumentsGENERATED RETINAL REFLEX IMAGERY SYSJul 12, 1984

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.