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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 K854330
Device Name IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM
Applicant
Par Technology Park
220 Seneca Tpke.
New Hartford,  NY  13413
Applicant Contact JAMES CAMBIER
Correspondent
Par Technology Park
220 Seneca Tpke.
New Hartford,  NY  13413
Correspondent Contact JAMES CAMBIER
Regulation Number886.1120
Classification Product Code
HKI  
Date Received10/28/1985
Decision Date 12/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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