Smart USBLite

GUDID 00817020020129

INTELLIGENT HEARING SYSTEMS CORP.

Otoacoustic emission system, line-powered Otoacoustic emission system, line-powered Otoacoustic emission system, line-powered

• Primary Device ID: 00817020020129
• NIH Device Record Key: a8b21424-8fce-436a-afea-627fd67b5faa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart USBLite
• Version Model Number: M011120
• Company DUNS: 154870455
• Company Name: INTELLIGENT HEARING SYSTEMS CORP.
• 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: 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	00817020020129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061443

FDA Product Code

• GWL: Amplifier, Physiological Signal

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: 2016-09-24

Devices Manufactured by INTELLIGENT HEARING SYSTEMS CORP.

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• 00817020020815 - SmartEP-ASSR Software: 2019-07-12
• 00817020020822 - SmartScreener-Plus2 Screener Launch: 2019-07-12
• 00817020020839 - SmartScreener-Plus2 AEP Module: 2019-07-12
• 00817020020846 - SmartScreener-Plus2 OAE Module: 2019-07-12