510(k) Report

Devices descending from K063433

1 later device reach Ultrasonic Biometer/Pachymeter for Opthalmology Odm 2100 and Odm 2200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222787Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C…Chongqing Sunkingdom Medical Instrument Co., Ltd.20230—