510(k) K182263

RetCam 3 ; RetCam Shuttle ; RetCam Portable by Natus Medical Incorporated — Product Code HKI

K182263 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated for the device "RetCam 3 ; RetCam Shuttle ; RetCam Portable". The FDA issued a decision of Substantially Equivalent on September 7, 2018. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Natus Medical Incorporated has at least 9 other 510(k) clearances on record.