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)

DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP

K-Number: K830215 · 1983-03-09

ApplicantJedmed Instrument Co.
Decision Date1983-03-09
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP is the device name listed in this FDA 510(k) record. The listed applicant is Jedmed Instrument Co.. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830215. 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 DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP?

DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K830215.

When did DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP receive FDA 510(k) clearance?

DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830215.

Who is the listed applicant for DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP?

The FDA 510(k) record lists Jedmed Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP?

The FDA product code for DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP 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 Jedmed Instrument Co. 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.

K021750LID CHAIN EYELID WEIGHTSK954184JED-LIGHT FIBEROPTIC LIGHT SOURCEK944032VIDEO SCOPE SYSTEM (LARYNGOSCOPE)K953457JEDMED SPECTRUM ENT CABINETK950925JEDMED LARYNGEAL SCOPEK950785HORTMANN AIRMATIC AIR CALORIC STIMULATOR

View all 91 devices →

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.

↑