LEVO

GUDID B400215930

OTOHARMONICS CORPORATION

Tinnitus masking application software Tinnitus masking application software

• Primary Device ID: B400215930
• NIH Device Record Key: 921287f6-d9a8-490a-bd95-71085201175c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEVO
• Version Model Number: PATIENT
• Company DUNS: 078763400
• Company Name: OTOHARMONICS CORPORATION
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B400215930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140845

FDA Product Code

• KLW: Masker, Tinnitus

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: 2018-11-05
• Device Publish Date: 2018-10-04

On-Brand Devices [LEVO]

• B400215930: PATIENT
• B400215720: MANAGER