BioStamp nPoint™

GUDID B493SW0027

Investigator application for Android

MC10, INC.

Kinesiology/electromyographic sensor set

• Primary Device ID: B493SW0027
• NIH Device Record Key: 7cebc094-1cde-43ba-947b-ce37ee455242
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioStamp nPoint™
• Version Model Number: SW-0027
• Company DUNS: 829221139
• Company Name: MC10, 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com
• Phone: 8572145630
• Email: support@mc10inc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B493SW0027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173510

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-08-31

On-Brand Devices [BioStamp nPoint™]

• B493SW0028: Web application
• B493SW0027: Investigator application for Android
• B493SW0026: Sync application for Android
• B493SW0025: Link application for Android
• B493MC0015: MC-0015 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
• B493MC0014: MC-0014 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA0
• B493MC0013: MC-0013 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
• B493MC0012: MC-0012 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
• B493MC0008: MC-0008 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
• B493MC0007: MC-0007 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA0
• B493MC0006: MC-0006 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
• B493MC0005: MC-0005 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
• B493MC0004: Discovery Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B493BRCP03, B493BRC
• B493MC0003: Exploratory Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B493BRCP03, B493B
• B493BRCT01: Mobile application tablet
• B493BRCP02: Mobile application phone
• B493BRCP01: Mobile application phone
• B493BRCD01: Link Hub smart charger