Holter Analysis Software NEMK162

GUDID M581NEMK1620

Holter Analysis Enhanced Plus

Northeast Monitoring, Inc.

Cardiac arrhythmia monitoring system

• Primary Device ID: M581NEMK1620
• NIH Device Record Key: db9ec4dd-5a29-41b4-b9c3-08e399329fea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holter Analysis Software
• Version Model Number: Enhanced Plus
• Catalog Number: NEMK162
• Company DUNS: 837441815
• Company Name: Northeast Monitoring, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M581NEMK1620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930564

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2021-11-04
• Device Publish Date: 2021-10-27

On-Brand Devices [Holter Analysis Software]

• M581NEMK1630: Holter Analysis Software Pro
• M581NEMK1620: Holter Analysis Enhanced Plus
• M581NEMK1610: Holter Analysis Software Enhanced
• M581NEMK1600: Holter Analysis Software Basic