KOWA KT-800

GUDID 04987646804109

The Kowa KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

KOWA COMPANY,LTD.

Ophthalmic tonometer, battery-operated

• Primary Device ID: 04987646804109
• NIH Device Record Key: eee1d92a-defe-48cc-881b-e9c889cc3db8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOWA KT-800
• Version Model Number: TO8K
• 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: 458 Millimeter
• Depth: 457 Millimeter
• Width: 274 Millimeter
• Weight: 18 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 60 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	04987646804109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053444

FDA Product Code

• HKX: Tonometer, 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

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