SleepImage System
K-Number: K182618 · 2019-08-14
Device Summary
Frequently Asked Questions
What is the SleepImage System?
SleepImage System is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Mycardio, LLC Dba Sleepimage.. The 510(k) number is K182618.
When did SleepImage System receive FDA 510(k) clearance?
SleepImage System received FDA 510(k) clearance on 2019-08-14, under 510(k) number K182618.
Who is the listed applicant for SleepImage System?
The FDA 510(k) record lists Mycardio, LLC Dba Sleepimage. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SleepImage System?
The FDA product code for SleepImage System is MNR.
Other records listing Mycardio, LLC Dba Sleepimage. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MNR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.