OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS— 510(k) K131719

Name: FDA 510(k) clearance K131719
Creator: U.S. Food and Drug Administration
Published: 2013-10-30

Substantially Equivalent

Medical Devices (Pvt) , Ltd.

FDA 510(k) clearance K131719 for OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS, Substantially Equivalent on 2013-10-30. Applicant: Medical Devices (Pvt) , Ltd.. Device class: 2.

Clearance details

Applicant: Medical Devices (Pvt) , Ltd.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2013-06-12
Decision date: 2013-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ugoki-Sialkot, PK

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.