510(k) Report

Devices descending from K913067

5 later devices reach DGH-4000 a-Scan/Pachymeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043287Palmscan AP2000; Palmscan A2000; Palmscan P2000Micromedical Devices, Inc.20043—
+1K012803AL-2000 Combined Biometer and PachymeterTomey Corp.20020—
+2K063472Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200Meda, Ltd.20072—
+3K121243Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterMEDA Co., Ltd.20131—
+4K152318MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd.20150—