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)

COMPREHENSIVE PHOROPTER, MDR-680

K-Number: K936205 · 1994-09-28

ApplicantCanon USA, Inc.
Decision Date1994-09-28
Product CodeHKN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COMPREHENSIVE PHOROPTER, MDR-680 is the device name listed in this FDA 510(k) record. The listed applicant is Canon USA, Inc.. It received FDA 510(k) clearance on 1994-09-28 under 510(k) number K936205. The device is classified under product code HKN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPREHENSIVE PHOROPTER, MDR-680?

COMPREHENSIVE PHOROPTER, MDR-680 is a medical device that received FDA 510(k) clearance on 1994-09-28. The listed applicant is Canon USA, Inc.. The 510(k) number is K936205.

When did COMPREHENSIVE PHOROPTER, MDR-680 receive FDA 510(k) clearance?

COMPREHENSIVE PHOROPTER, MDR-680 received FDA 510(k) clearance on 1994-09-28, under 510(k) number K936205.

Who is the listed applicant for COMPREHENSIVE PHOROPTER, MDR-680?

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

What is the FDA product code for COMPREHENSIVE PHOROPTER, MDR-680?

The FDA product code for COMPREHENSIVE PHOROPTER, MDR-680 is HKN.

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 Canon USA, 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.

K090623DIGITAL RADIOGRAPHY CXDI-40G COMPACTK033624PACS SOFTWARE SOLUTION 2003K031633CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40CK031629CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGIK023750CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40GK023586DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS

View all 48 devices →

Related Devices (Code: HKN)

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.

K874900WOODLYN CLASSIC REFRACTOR, PHOROPTORWoodlyn, Inc.K782118FUL-VUEAmerican Optical Corp.

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.

↑