Nihon Kohden, EEG-1200A Series Neurofax KE-122A-01

GUDID 04931921007730

Cart, Compact type, used with EEG-1200A, works with standard and optional accessories

NIHON KOHDEN CORPORATION

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• Primary Device ID: 04931921007730
• NIH Device Record Key: df9ee541-b782-4137-91a3-28e0706b7aeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nihon Kohden, EEG-1200A Series Neurofax
• Version Model Number: KE-122A-01
• Catalog Number: KE-122A-01
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN 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: true
• Serial Number: false
• 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: 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	04931921007730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080546

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: 2023-10-09
• Device Publish Date: 2019-07-24

On-Brand Devices [Nihon Kohden, EEG-1200A Series Neurofax]

• 04931921007716: Flash lamp assembly, Round shape
• 04931921007709: Flash lamp assembly
• 04931921007631: Electrode junction box, Standard accessory
• 04931921007730: Cart, Compact type, used with EEG-1200A, works with standard and optional accessories
• 04931921007723: Cart, used with EEG-1200A, works with standard and optional accessories