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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Battery-Powered
510(k) Number K053425
Device Name PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
Applicant
Precision Optics Corp.
22 E. Broadway
Gardner,  MA  01440
Applicant Contact ERWIN HEIDER
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact NEIL E DEVINE
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received12/08/2005
Decision Date 01/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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