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)

KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C

K-Number: K954780 · 1995-12-01

ApplicantKowa Optimed, Inc.
Decision Date1995-12-01
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Optimed, Inc.. It received FDA 510(k) clearance on 1995-12-01 under 510(k) number K954780. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C?

KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C is a medical device that received FDA 510(k) clearance on 1995-12-01. The listed applicant is Kowa Optimed, Inc.. The 510(k) number is K954780.

When did KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C receive FDA 510(k) clearance?

KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C received FDA 510(k) clearance on 1995-12-01, under 510(k) number K954780.

Who is the listed applicant for KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C?

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

What is the FDA product code for KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C?

The FDA product code for KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C is HKI.

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 Kowa Optimed, 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.

K013805KOWA AUTOMATED TONOMETER KT-500K961090AUTOMATIC VISUAL FIELD PLOTTER AP-125K960924KOWA HAND-HELD APPLANATION TONOMETER HA-1K955442KOWA SC-1200 PHOTO SLIT LAMP SYSTEMK954781KOWA GENESIS HAND-HELD FUNDUS CAMERAK954782KOWA PORTABLE SLIT LAMP SL-14 & SL-14B

View all 10 devices →

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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.

↑