Neuromaster MEE-2000A-LT

GUDID 00841983103629

MEE-2000 Neuromaster G1 Laptop system; performs Intraoperative and Evoked Potential studies

NIHON KOHDEN AMERICA, INC.

Evoked-potential graphic recording system

• Primary Device ID: 00841983103629
• NIH Device Record Key: bd0310d9-3141-455e-ac3f-bc67c6f7284d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuromaster
• Version Model Number: MEE-2000A-LT
• Catalog Number: MEE-2000A-LT
• Company DUNS: 021063219
• Company Name: NIHON KOHDEN AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841983103629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142624

FDA Product Code

• GWF: STIMULATOR, ELECTRICAL, EVOKED RESPONSE

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: 2016-09-24

On-Brand Devices [Neuromaster]

• 00841983103629: MEE-2000 Neuromaster G1 Laptop system; performs Intraoperative and Evoked Potential studies
• 00841983103612: MEE-2000 Neuromaster G1 Desktop system; performs Intraoperative and Evoked Potential studies
• 00841983103605: MEE-1000 Neuromaster Laptop system; performs Intraoperative and Evoked Potential studies
• 00841983103599: MEE-1000 Neuromaster desktop system; performs Intraoperative and Evoked Potential studies
• 00841983102233: Main unit for MEE-1000A