Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPECTACLE INDIRECT OPHTHALMOSCOPE

K-Number: K841292 · 1984-05-09

ApplicantKeller Instruments, Inc.
Decision Date1984-05-09
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Keller Instruments, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K841292. 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 SPECTACLE INDIRECT OPHTHALMOSCOPE?

SPECTACLE INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Keller Instruments, Inc.. The 510(k) number is K841292.

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

SPECTACLE INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1984-05-09, under 510(k) number K841292.

Who is the listed applicant for SPECTACLE INDIRECT OPHTHALMOSCOPE?

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

What is the FDA product code for SPECTACLE INDIRECT OPHTHALMOSCOPE?

The FDA product code for SPECTACLE INDIRECT OPHTHALMOSCOPE is HLJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Keller Instruments, 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.

K854541TIP OFF FORCEPSK841294ACU220 CRYO UNITK841293PANORAMIC LOUPES - VARIOUSK823835SPEMBLY 140 CRYOSYSTEM PROBES & TIPS

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.

↑