Neuro Kinetics Inc NOTC

GUDID B290NOTC0

Nystagmograph

N K I

Caloric vestibular-stimulation system Caloric vestibular-stimulation system

• Primary Device ID: B290NOTC0
• NIH Device Record Key: 1a65f6ea-5309-41fe-9fa1-d523417c1192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro Kinetics Inc
• Version Model Number: NOTC
• Catalog Number: NOTC
• Company DUNS: 151391174
• Company Name: N K I
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B290NOTC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143607

FDA Product Code

• GWN: Nystagmograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-06
• Device Publish Date: 2017-02-13

Devices Manufactured by N K I

• B290NOTC0 - Neuro Kinetics Inc: 2020-01-06Nystagmograph
• B290NOTC0 - Neuro Kinetics Inc: 2020-01-06 Nystagmograph
• B290SVNG0 - I-Portal Super VNG: 2020-01-06 Video-Nystagmograph
• B290SVNG1 - I-Portal Super VNG: 2018-07-06 Video-Nystagmograph
• B290IPAS0 - I-Portal Portable Assessment System: 2018-06-15 Nystagmograph