KOWA VX-10

GUDID 04987646802006

KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.

KOWA COMPANY,LTD.

Ophthalmic fundus camera

• Primary Device ID: 04987646802006
• NIH Device Record Key: 4d1a3f30-e96c-4efd-a2be-c847d9086bee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOWA VX-10
• Version Model Number: K9L48K
• Company DUNS: 692281073
• Company Name: KOWA COMPANY,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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 620 Millimeter
• Depth: 520 Millimeter
• Width: 400 Millimeter
• Weight: 39 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987646802006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043213

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

Devices Manufactured by KOWA COMPANY,LTD.

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• 04987646807728 - KOWA DR-1α: 2019-06-18 The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician