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FDA 510(k)

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS

K-Number: K131719 · 2013-10-30

ApplicantMedical Devices (Pvt) , Ltd.
Decision Date2013-10-30
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices (Pvt) , Ltd.. It received FDA 510(k) clearance on 2013-10-30 under 510(k) number K131719. The device is classified under product code HLJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS?

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS is a medical device that received FDA 510(k) clearance on 2013-10-30. The listed applicant is Medical Devices (Pvt) , Ltd.. The 510(k) number is K131719.

When did OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS receive FDA 510(k) clearance?

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS received FDA 510(k) clearance on 2013-10-30, under 510(k) number K131719.

Who is the listed applicant for OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS?

The FDA 510(k) record lists Medical Devices (Pvt) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS?

The FDA product code for OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS is HLJ.

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Related Devices (Code: HLJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131961HEINE BETA 200(R) OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK123587HEINE MINI 3000 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSAmerican Diagnostic Corp.K070270PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36Kirchner & Wilhelm GmbH + Co.KgK05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25ASuzhou 66 Vision Tech Co., Ltd.K061278OPTYSE OPHTHALMOSCOPEOphthalmos , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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