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)

F110 PHOTO BINOCULAR OPHTHALMOSCOPE

K-Number: K802351 · 1980-12-17

ApplicantMinami, Tomine & Lew
Decision Date1980-12-17
Product CodeHLG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

F110 PHOTO BINOCULAR OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Minami, Tomine & Lew. It received FDA 510(k) clearance on 1980-12-17 under 510(k) number K802351. The device is classified under product code HLG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F110 PHOTO BINOCULAR OPHTHALMOSCOPE?

F110 PHOTO BINOCULAR OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1980-12-17. The listed applicant is Minami, Tomine & Lew. The 510(k) number is K802351.

When did F110 PHOTO BINOCULAR OPHTHALMOSCOPE receive FDA 510(k) clearance?

F110 PHOTO BINOCULAR OPHTHALMOSCOPE received FDA 510(k) clearance on 1980-12-17, under 510(k) number K802351.

Who is the listed applicant for F110 PHOTO BINOCULAR OPHTHALMOSCOPE?

The FDA 510(k) record lists Minami, Tomine & Lew as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F110 PHOTO BINOCULAR OPHTHALMOSCOPE?

The FDA product code for F110 PHOTO BINOCULAR OPHTHALMOSCOPE is HLG.

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

Related Devices (Code: HLG)

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.

K920937COMPUTERIZED PUPILTrek Medical Products, Inc.K895609PUPIL PATHWAY ANALYZER (PPA)Pulse Medical Instruments

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.

↑