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FDA 510(k)

INDIRECT OPHTHALMOSCOPE

K-Number: K853891 · 1985-10-04

ApplicantCarl Zeiss, Inc.
Decision Date1985-10-04
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853891. 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 INDIRECT OPHTHALMOSCOPE?

INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K853891.

When did INDIRECT OPHTHALMOSCOPE receive FDA 510(k) clearance?

INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853891.

Who is the listed applicant for INDIRECT OPHTHALMOSCOPE?

The FDA 510(k) record lists Carl Zeiss, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDIRECT OPHTHALMOSCOPE?

The FDA product code for INDIRECT OPHTHALMOSCOPE is HLJ.

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Other records listing Carl Zeiss, Inc. as applicant

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.

K013402VISULAS 532SK003885VISULAS YAG IIK993357IOLMASTERK983868OPMI TWINER SURGICAL MICROSCOPEK965139SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEMK961380CPC PROBE

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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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