SleepImage

GUDID B315SLEEPIMAGECOM0

Web based software

MYCARDIO LLC

Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier

• Primary Device ID: B315SLEEPIMAGECOM0
• NIH Device Record Key: 0ac776e3-3458-429f-a9b1-a71029bef014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepImage
• Version Model Number: 8
• Company DUNS: 964500776
• Company Name: MYCARDIO LLC
• 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: 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
HIBCC	B315SLEEPIMAGECOM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092003

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2017-01-17

Devices Manufactured by MYCARDIO LLC

• B315SLEEPIMAGESYSTEMD8 - SleepImage System: 2023-11-20 The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, dis
• B315SLEEPIMAGECOM0 - SleepImage: 2018-07-06Web based software
• B315SLEEPIMAGECOM0 - SleepImage: 2018-07-06 Web based software