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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K203500
Device Name RetCam Envision
Applicant
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
2568 Bristol Cir.
Oakville,  CA l6h 5s1
Applicant Contact Sanjay Mehta
Correspondent
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
2568 Bristol Cir.
Oakville,  CA l6h 5s1
Correspondent Contact Sanjay Mehta
Regulation Number886.1120
Classification Product Code
HKI  
Date Received11/30/2020
Decision Date 04/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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