SleepImage

GUDID B315SLEEPIMAGECOM0

Web based software

MYCARDIO LLC

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