Fundus Camera HFC-1 HFC-1

GUDID 08800019600541

HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.

Huvitz Co., Ltd.

Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera

• Primary Device ID: 08800019600541
• NIH Device Record Key: 80c408b8-0f0a-4fae-b8c8-7b001e17245a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fundus Camera HFC-1
• Version Model Number: HFC-1
• Catalog Number: HFC-1
• Company DUNS: 688154202
• Company Name: Huvitz Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019600541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202097

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-17
• Device Publish Date: 2021-02-09

Devices Manufactured by Huvitz Co., Ltd.

• 08800019600787 - Optical Biometer HBM-1: 2023-10-26 The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature
• 08800019600916 - Digital Refractor HDR-7100P: 2023-09-01 The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the p
• 08800019600923 - Auto Ref/Keratometer HRK-8100A: 2023-09-01 Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the ref
• 08800019600411 - Applanation Tonometer HT-5000: 2023-06-20 Applanation Tonometer HT-5000
• 08800019600435 - Non-contact Tonometer HNT-1P: 2023-06-20 Non-contact Tonometer HNT-1P
• 08800019600503 - Ref-Keratometer ERK-9100: 2023-06-20 Ref-Keratometer ERK-9100
• 08800019600558 - Auto Tono/Refracto/Kerato/Pachymeter HTR-1A: 2023-06-20 Auto Tono/Refracto/Kerato/Pachymeter HTR-1A
• 08800019600732 - Digital Chart HDC-9100N: 2023-06-20 Digital Chart HDC-9100N