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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 K131719
Device Name OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
Applicant
Medical Devices (Pvt) , Ltd.
Wazirabad Rd.
Ugoki-Sialkot,  PK PK
Applicant Contact TAUSEEF AJMAL
Correspondent
Medical Devices (Pvt) , Ltd.
Wazirabad Rd.
Ugoki-Sialkot,  PK PK
Correspondent Contact TAUSEEF AJMAL
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received06/12/2013
Decision Date 10/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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