JE-922A

GUDID 00841983102493

Mini electrode junction box, JE-921A

NIHON KOHDEN AMERICA, INC.

Electroencephalograph

• Primary Device ID: 00841983102493
• NIH Device Record Key: cbba7040-0a68-48e2-818d-22645ef34f2b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: JE-922A
• Catalog Number: JE-922A
• 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: 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

Customer Support Contacts

• Phone: +1(800)325-0283
• Email: info@nkusa.com
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00841983102493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011204

FDA Product Code

• OLT: Non-normalizing quantitative electroencephalograph software

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

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