ADVANCED FETAL MONITOR

GUDID B510FM9000

ADVANCED INSTRUMENTATIONS, INC.

Foetal/maternal prenatal monitor

• Primary Device ID: B510FM9000
• NIH Device Record Key: a8efc4af-19ac-40d1-aefa-e51ff3e48961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED FETAL MONITOR
• Version Model Number: FM-9000
• Company DUNS: 608736880
• Company Name: ADVANCED INSTRUMENTATIONS, 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: true
• 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
HIBCC	B510FM9000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112317

FDA Product Code

• HGM: System, Monitoring, Perinatal

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: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [ADVANCED FETAL MONITOR]

• B510FM9000PLUSD1: FM-9000 PLUS D
• B510FM9000PLUS1: FM-9000 PLUS
• B510FM30001: FM-3000
• B510FM9000: FM-9000