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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 K223381
Device Name iExaminer System with Panoptic Plus
Applicant
Welch Allyn, Inc.
(a subsidiary of Baxter Healthcare Corporation)
4341 State Street Road
Skaneateles Falls,  NY  13153
Applicant Contact Jeffrey E. Thompson
Correspondent
Welch Allyn, Inc.
(a subsidiary of Baxter Healthcare Corporation)
4341 State Street Road
Skaneateles Falls,  NY  13153
Correspondent Contact Jeffrey E. Thompson
Regulation Number886.1120
Classification Product Code
HKI  
Date Received11/07/2022
Decision Date 03/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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