SERIES-5 MyoVision ScanVision D2-D7-D7

GUDID 00853818007446

SERIES-5 VisionHUB with ScanVision Static sEMG Scanners

PRECISION BIOMETRICS INC

Multiple physiological signal amplifier

• Primary Device ID: 00853818007446
• NIH Device Record Key: bfef46fd-00fa-4452-b029-d7392df834bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SERIES-5 MyoVision ScanVision
• Version Model Number: D2-D7-D7
• Catalog Number: D2-D7-D7
• Company DUNS: 362997926
• Company Name: PRECISION BIOMETRICS 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853818007446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123399

FDA Product Code

• KQX: Goniometer, Ac-Powered

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: 2021-03-08
• Device Publish Date: 2021-02-28

On-Brand Devices [SERIES-5 MyoVision ScanVision]

• 00853818007446: SERIES-5 VisionHUB with ScanVision Static sEMG Scanners
• 00853818007439: SERIES-5 VisionHUB with ScanVision Static sEMG Scanner