VitalEEG Portable System WSS-002-ZA

GUDID 00841983104282

Nihon Kohden VitalEEG Portable system with AE-120A EEG Head Set and Nihon Kohden EEG Acquisition System.

NIHON KOHDEN AMERICA, INC.

Electroencephalograph

• Primary Device ID: 00841983104282
• NIH Device Record Key: 34ebe215-3b58-424c-93f8-01188bfc6c2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalEEG Portable System
• Version Model Number: WSS-002-ZA
• Catalog Number: WSS-002-ZA
• Company DUNS: 021063219
• Company Name: NIHON KOHDEN AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841983104282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183529

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

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: 2021-04-06
• Device Publish Date: 2021-03-29

On-Brand Devices [VitalEEG Portable System]

• 00841983104275: Nihon Kohden VitalEEG Portable system with AE-120A EEG Head Set and Nihon Kohden EEG Acquisition
• 00841983104282: Nihon Kohden VitalEEG Portable system with AE-120A EEG Head Set and Nihon Kohden EEG Acquisition