510(k) K182618
K182618 is an FDA 510(k) premarket notification submitted by Mycardio, LLC Dba Sleepimage. for the device "SleepImage System". The FDA issued a decision of Substantially Equivalent on Aug 14, 2019. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Mycardio, LLC Dba Sleepimage. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 14, 2019
- Date Received
- Sep 24, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type
- 510(k)