WAVi Co

GUDID B592WH200

Small Headset

WAVI CO.

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode

• Primary Device ID: B592WH200
• NIH Device Record Key: df22ade3-a9fc-4b2a-a28e-5b090f7934c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVi Co
• Version Model Number: WH200
• Company DUNS: 007785282
• Company Name: WAVI CO.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B592WH200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162460

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2019-03-19
• Device Publish Date: 2019-03-11

Devices Manufactured by WAVI CO.

• B592WE100 - WAVi Co.: 2019-03-19
• B592WE200 - WAVi Co.: 2019-03-19
• B592WH200 - WAVi Co: 2019-03-19Small Headset
• B592WH200 - WAVi Co: 2019-03-19 Small Headset
• B592WH300 - WAVi Co.: 2019-03-19
• B592WH400 - WAVi Co.: 2019-03-19
• B592WH500 - WAVi Co.: 2019-03-19