OPTICAL BIOMETER

GUDID 04573344510017

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular me

SANTEC CORPORATION

Keratometer

• Primary Device ID: 04573344510017
• NIH Device Record Key: 2ccd1453-e889-45b1-9c6e-cdf508056060
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTICAL BIOMETER
• Version Model Number: ARGOS
• Company DUNS: 704295641
• Company Name: SANTEC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573344510017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150754

FDA Product Code

• MXK: Device,Analysis,Anterior Segment

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: 2017-05-01

On-Brand Devices [OPTICAL BIOMETER ]

• 04573344510017: ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography
• 04573344510024: ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherencetomography