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FDA 510(k)

HALOGEN DIAGNOSTIC SET BX A - 12345

K-Number: K950796 · 1995-03-22

ApplicantNeitz Instruments Company, Ltd.
Decision Date1995-03-22
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HALOGEN DIAGNOSTIC SET BX A - 12345 is the device name listed in this FDA 510(k) record. The listed applicant is Neitz Instruments Company, Ltd.. It received FDA 510(k) clearance on 1995-03-22 under 510(k) number K950796. 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 HALOGEN DIAGNOSTIC SET BX A - 12345?

HALOGEN DIAGNOSTIC SET BX A - 12345 is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Neitz Instruments Company, Ltd.. The 510(k) number is K950796.

When did HALOGEN DIAGNOSTIC SET BX A - 12345 receive FDA 510(k) clearance?

HALOGEN DIAGNOSTIC SET BX A - 12345 received FDA 510(k) clearance on 1995-03-22, under 510(k) number K950796.

Who is the listed applicant for HALOGEN DIAGNOSTIC SET BX A - 12345?

The FDA 510(k) record lists Neitz Instruments Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALOGEN DIAGNOSTIC SET BX A - 12345?

The FDA product code for HALOGEN DIAGNOSTIC SET BX A - 12345 is HLJ.

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Other records listing Neitz Instruments Company, Ltd. as applicant

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K972440CATARACTSCREENER CT - SK951341NEITZ SLIT LAMP SL-H2K951337FIBER HEAD LIGHT FH-300K950788OTOSCOPE A-34K951340NEITZ SLIT LAMP SL-H1K951338INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV

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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. KGK131719OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITSMedical Devices (Pvt) , Ltd.K123587HEINE 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.

Official Source

View on FDA Database →

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

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