MRI Patient Monitoring System Tesla M3 1800001

GUDID EMIP18000010

The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.

MIPM Mammendorfer Institut für Physik und Medizin GmbH

MRI-patient physiologic monitoring system

• Primary Device ID: EMIP18000010
• NIH Device Record Key: b6835f20-40d4-4fd7-9f56-677d98009ebf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRI Patient Monitoring System Tesla M3
• Version Model Number: TeslaM3
• Catalog Number: 1800001
• Company DUNS: 324416379
• Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH
• 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: +49814592090
• Email: info@mipm.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMIP18000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142032

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: 2018-07-06
• Device Publish Date: 2016-08-25

On-Brand Devices [MRI Patient Monitoring System Tesla M3]

• EMIP18000010: The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI
• 04255629200485: The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI